Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-25 @ 3:47 AM
Study NCT ID:
NCT02610868
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2015-11-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012798', 'term': 'Sialorrhea'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C096323', 'term': 'rimabotulinumtoxinB'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'regulatoryaffairs@usworldmeds.com', 'phone': '502-815-8148', 'title': 'Regulatory Affairs Specialist', 'organization': 'Solstice Neurosciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'through study completion, up to 1 year', 'description': 'Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.', 'eventGroups': [{'id': 'EG000', 'title': 'MYOBLOC: Treatment Session 1', 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 44, 'seriousNumAtRisk': 187, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'MYOBLOC: Treatment Session 2', 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 177, 'otherNumAffected': 34, 'seriousNumAtRisk': 177, 'deathsNumAffected': 4, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'MYOBLOC: Treatment Session 3', 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 7, 'seriousNumAtRisk': 50, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'MYOBLOC: Treatment Session 4', 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'ALL MYOBLOC: Treatment Sessions 1-4', 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1, Weeks 4 and 13 for Treatment Sessions 2-4.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 73, 'seriousNumAtRisk': 187, 'deathsNumAffected': 8, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amyotrophic lateral sclerosis', 'notes': 'Captured ALS subjects progression of disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural compication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple system atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amyotrophic lateral sclerosis', 'notes': 'Captured ALS subjects progression of disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Freezing phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG001', 'title': 'Treatment Session 2', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG002', 'title': 'Treatment Session 3', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG003', 'title': 'Treatment Session 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}], 'classes': [{'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Severe TEAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Related to Study Medication', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1', 'description': 'TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related.\n\nTreatment Session (TS)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U or 3000 U).'}, {'type': 'PRIMARY', 'title': 'Occurrence of Adverse Events of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG001', 'title': 'Treatment Session 2', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG002', 'title': 'Treatment Session 3', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG003', 'title': 'Treatment Session 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}], 'classes': [{'title': 'Aspiration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Aspirational pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Choking', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dysphagia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1', 'description': 'Treatment Session (TS)\n\nAESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'PRIMARY', 'title': 'Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '166', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Suicidal Behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit.\n\nPer protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Occurrence of Dental Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG001', 'title': 'Treatment Session 2', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG002', 'title': 'Treatment Session 3', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}, {'id': 'OG003', 'title': 'Treatment Session 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1', 'description': 'Treatment Session (TS)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}, {'value': '166', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3424', 'spread': '0.3685', 'groupId': 'OG000'}, {'value': '-0.2771', 'spread': '0.3144', 'groupId': 'OG001'}, {'value': '-0.1357', 'spread': '0.2888', 'groupId': 'OG002'}, {'value': '-0.2272', 'spread': '0.2668', 'groupId': 'OG003'}, {'value': '-0.0560', 'spread': '0.2067', 'groupId': 'OG004'}, {'value': '-0.1797', 'spread': '0.1975', 'groupId': 'OG005'}, {'value': '-0.0547', 'spread': '0.2269', 'groupId': 'OG006'}, {'value': '-0.1592', 'spread': '0.2305', 'groupId': 'OG007'}, {'value': '-0.0335', 'spread': '0.1378', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1131', 'groupIds': ['OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0026', 'groupIds': ['OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2569', 'groupIds': ['OG008'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1.\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.', 'unitOfMeasure': 'g/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression of Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '167', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '1.12', 'groupId': 'OG003'}, {'value': '-0.1', 'spread': '0.99', 'groupId': 'OG004'}, {'value': '-0.9', 'spread': '1.13', 'groupId': 'OG005'}, {'value': '-0.2', 'spread': '0.90', 'groupId': 'OG006'}, {'value': '-0.9', 'spread': '0.95', 'groupId': 'OG007'}, {'value': '-0.3', 'spread': '1.02', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3130', 'groupIds': ['OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1054', 'groupIds': ['OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1663', 'groupIds': ['OG008'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients".\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Change (CGI-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '167', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '1.04', 'groupId': 'OG003'}, {'value': '3.1', 'spread': '1.34', 'groupId': 'OG004'}, {'value': '2.4', 'spread': '0.94', 'groupId': 'OG005'}, {'value': '3.0', 'spread': '1.06', 'groupId': 'OG006'}, {'value': '2.5', 'spread': '0.93', 'groupId': 'OG007'}, {'value': '2.8', 'spread': '0.94', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse".\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.\n\nTreatment Session (TS)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '783', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '167', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.37', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '1.52', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '1.30', 'groupId': 'OG004'}, {'value': '-1.1', 'spread': '1.36', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '1.33', 'groupId': 'OG006'}, {'value': '-1.5', 'spread': '1.44', 'groupId': 'OG007'}, {'value': '-0.3', 'spread': '0.71', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1100', 'groupIds': ['OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0290', 'groupIds': ['OG008'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools.\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.\n\nThe severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '162', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.49', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.90', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.98', 'groupId': 'OG004'}, {'value': '-0.4', 'spread': '0.64', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '1.00', 'groupId': 'OG006'}, {'value': '-0.4', 'spread': '1.03', 'groupId': 'OG007'}, {'value': '-0.2', 'spread': '1.37', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9016', 'groupIds': ['OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0753', 'groupIds': ['OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4992', 'groupIds': ['OG008'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools.\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.\n\nThe severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Impression of Severity (PGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}, {'value': '167', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.59', 'spread': '1.548', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '1.461', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '1.364', 'groupId': 'OG002'}, {'value': '-0.78', 'spread': '1.303', 'groupId': 'OG003'}, {'value': '-0.07', 'spread': '1.245', 'groupId': 'OG004'}, {'value': '-0.94', 'spread': '1.248', 'groupId': 'OG005'}, {'value': '0.04', 'spread': '1.242', 'groupId': 'OG006'}, {'value': '-1.38', 'spread': '1.279', 'groupId': 'OG007'}, {'value': '-0.26', 'spread': '1.251', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4567', 'groupIds': ['OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8115', 'groupIds': ['OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3282', 'groupIds': ['OG008'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill".\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGI-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}, {'value': '167', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.13', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.06', 'groupId': 'OG003'}, {'value': '3.2', 'spread': '1.28', 'groupId': 'OG004'}, {'value': '2.7', 'spread': '0.95', 'groupId': 'OG005'}, {'value': '3.2', 'spread': '1.10', 'groupId': 'OG006'}, {'value': '2.5', 'spread': '0.72', 'groupId': 'OG007'}, {'value': '3.4', 'spread': '0.72', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse".\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Drooling Impact Score (DIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '167', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Session 1: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG001', 'title': 'Treatment Session 1: Week 8', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG002', 'title': 'Treatment Session 1: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.'}, {'id': 'OG003', 'title': 'Treatment Session 2: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG004', 'title': 'Treatment Session 2: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.'}, {'id': 'OG005', 'title': 'Treatment Session 3: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG006', 'title': 'Treatment Session 3: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.'}, {'id': 'OG007', 'title': 'Treatment Session 4: Week 4', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}, {'id': 'OG008', 'title': 'Treatment Session 4: Week 13', 'description': 'Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '5.33', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '5.16', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '4.97', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '4.17', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '3.94', 'groupId': 'OG004'}, {'value': '-2.8', 'spread': '3.39', 'groupId': 'OG005'}, {'value': '-0.1', 'spread': '2.11', 'groupId': 'OG006'}, {'value': '-3.6', 'spread': '3.10', 'groupId': 'OG007'}, {'value': '-0.5', 'spread': '2.57', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3786', 'groupIds': ['OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7787', 'groupIds': ['OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG007'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3825', 'groupIds': ['OG008'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities).\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.\n\nSubject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MYOBLOC: 3500U', 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments.'}], 'periods': [{'title': 'MYOBLOC: Treatment Session 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}, {'title': 'MYOBLOC: Treatment Session 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}, {'title': 'MYOBLOC: Treatment Session 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}, {'title': 'MYOBLOC: Treatment Session 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.', 'preAssignmentDetails': 'All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MYOBLOC', 'description': 'MYOBLOC: After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1; Weeks 4, 13 for Treatment Sessions 2-4.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '175', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}, {'title': 'Belarus', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Unstimulated Salivary Flow Rate (USFR)', 'classes': [{'categories': [{'measurements': [{'value': '0.6322', 'spread': '0.4918', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression of Severity (CGI-S)', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.94', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale (1-7)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Global Impression of Severity (PGI-S)', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale (1-7)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Eligible subjects included male or females aged 18 to 85 years who are seeking treatment for troublesome sialorrhea for at least 3 months before screening.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-23', 'size': 1313741, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-06T14:37', 'hasProtocol': True}, {'date': '2018-07-22', 'size': 461035, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-06T14:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'dispFirstSubmitDate': '2018-05-30', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2015-11-02', 'dispFirstSubmitQcDate': '2018-05-30', 'resultsFirstSubmitDate': '2019-09-06', 'studyFirstSubmitQcDate': '2015-11-19', 'dispFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-01', 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE)', 'timeFrame': 'Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1', 'description': 'TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related.\n\nTreatment Session (TS)'}, {'measure': 'Occurrence of Adverse Events of Special Interest (AESI)', 'timeFrame': 'Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1', 'description': 'Treatment Session (TS)\n\nAESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia.'}, {'measure': 'Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit.\n\nPer protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.\n\nAll subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).'}, {'measure': 'Occurrence of Dental Adverse Events', 'timeFrame': 'Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1', 'description': 'Treatment Session (TS)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1.\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.'}, {'measure': 'Change From Baseline in Clinical Global Impression of Severity (CGI-S)', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients".\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.'}, {'measure': 'Clinical Global Impression of Change (CGI-C)', 'timeFrame': 'TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse".\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.\n\nTreatment Session (TS)'}, {'measure': 'Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools.\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.\n\nThe severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools.\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.\n\nThe severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill".\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.'}, {'measure': 'Patient Global Impression of Change (PGI-C)', 'timeFrame': 'TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse".\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.'}, {'measure': 'Change From Baseline in Drooling Impact Score (DIS)', 'timeFrame': 'Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13', 'description': 'The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities).\n\nTreatment Session (TS)\n\nParticipants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.\n\nSubject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'ALS', 'Stroke', 'Neuroleptics'], 'conditions': ['Sialorrhea']}, 'referencesModule': {'references': [{'pmid': '40498248', 'type': 'DERIVED', 'citation': 'Pahwa R, Molho E, Lew M, Dashtipour K, Gil RA, Revilla FJ, Clinch T, Qin P, Isaacson SH; OPen Label Trial of Intraglandular MYobloc injections for Sialorrhea Treatment (OPTIMYST) study group. Long-Term Safety and Efficacy of Repeated Cycles of RimabotulinumtoxinB in the Treatment of Chronic Sialorrhea: Results of the OPTIMYST Trial. Neurol Ther. 2025 Aug;14(4):1553-1567. doi: 10.1007/s40120-025-00777-z. Epub 2025 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.', 'detailedDescription': 'Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. The primary goal is to determine the long-term safety and tolerability of MYOBLOC (administered intraglandularly as single total dose of 3,500 Units) treatments every 13 weeks over a maximum possible duration of 1 year in adult subjects with troublesome sialorrhea. The secondary goal is to assess the magnitude of therapeutic response of MYOBLOC (administered intraglandularly as a single total dose of 3,500 Units) using effectiveness assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications.\n* Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent.\n* Male or female, 18 to 85 years of age (inclusive).\n* Minimum unstimulated salivary flow rate of 0.2 g/min at screening\n* Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening.\n* Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis\n\nExclusion Criteria:\n\n* A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate.\n* Respiratory forced vital capacity (FVC) of \\<20% of predicted\n* Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening\n* Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete).\n* Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function\n* Prior salivary gland surgery\n* Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary\n* Evidence of any clinically significant neurologic disease\n* Pregnancy or lactation\n* Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation.\n* Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening.\n* Current infection at the sialorrhea treatment injection site(s)\n* History of drug or alcohol abuse currently or within the previous 6 months\n* Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study"}, 'identificationModule': {'nctId': 'NCT02610868', 'acronym': 'OPTIMYST', 'briefTitle': 'Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3, Long-Term, Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects', 'orgStudyIdInfo': {'id': 'SN-SIAL-351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MYOBLOC Injection', 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections over the course of 1 year.', 'interventionNames': ['Drug: MYOBLOC']}], 'interventions': [{'name': 'MYOBLOC', 'type': 'DRUG', 'otherNames': ['rimabotulinumtoxinB', 'botulinum toxin type B'], 'description': 'After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13, 17, 26, 30, 39, 43, and 52, and telephone follow up will occur at Weeks 21, 34, and 47', 'armGroupLabels': ['MYOBLOC Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 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'country': 'Ukraine', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '76008', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '79010', 'city': 'Lviv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '65025', 'city': 'Odesa', 'country': 'Ukraine', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '33010', 'city': 'Rivne', 'country': 'Ukraine', 'geoPoint': {'lat': 50.62036, 'lon': 26.23695}}, {'zip': '88018', 'city': 'Uzhhorod', 'country': 'Ukraine', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'zip': '69600', 'city': 'Zaporizhzhya', 'country': 'Ukraine', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}], 'overallOfficials': [{'name': 'Najeebah Abdul-Musawir, MD,MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Supernus Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Supernus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}