Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-29 @ 4:39 AM
Study NCT ID:
NCT05216250
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Tremor Disability Scale-Revised (TREDS-R) Total Score Across 7 Unilateral Items', 'timeFrame': 'Week 24', 'description': 'Tremor Disability Scale-Revised (TREDS-R) is a scale to assess activities of daily living (ADL) through a self-questionnaire asking participants to rate how easy or difficult it is to perform a particular activity. The scale consists of 20 items with each item rated on a scale of 1 (able to do the activity without difficulty) to 4 (cannot do the activity by yourself). 7 items included in this subset will be: use a spoon to drink soup, hold a cup of tea, pour milk from a bottle or carton, dial a telephone, pick up your change in a shop, insert an electric plug into a socket, unlock your front door with a key.'}, {'measure': 'Number of Participants with Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Up to approximately 36 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in TETRAS Activity of Daily Living (TETRAS ADL) Total Score Across 5 Unilateral Items', 'timeFrame': 'Week 24', 'description': "TETRAS Activity of Daily Living (TETRAS ADL) is a clinical rating scale using the total score across 5 unilateral items of the analyzed 10-item TETRAS ADL, with each item's recorded scores of 0 and 1 (0-4 scale) combined into one category with a score of 1 for analysis on a 1-4 scale.\n\nThe 5 tasks included in this subset will be feeding with a spoon, drinking from a glass, pouring, using keys, and writing."}, {'measure': 'Change From Baseline in TETRAS Archimedes Spiral Score', 'timeFrame': 'Week 24', 'description': 'Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Archimedes Spiral is an item of the TETRAS performance subscale that is designed to assess tremor severity. During this test, participants are instructed to draw an unbroken spiral which is then scored from 0 to 4, with 1 being tremor is "barely visible" and 4 being "figure not recognizable."'}, {'measure': 'Change From Baseline in TETRAS Handwriting Score', 'timeFrame': 'Week 24', 'description': 'TETRAS Handwriting is an item of the TETRAS performance subscale that is designed to assess tremor severity. During this test, participants are instructed to write the standard sentence "This is a sample of my best handwriting" using the dominant hand only, which is then scored from 0 to 4 with 1 being tremor is "slight: untidy due to tremor that is barely visible" and 4 being "severe: completely illegible."'}, {'measure': 'Change From Baseline in Clinical Global Impression of Severity (CGI-S)', 'timeFrame': 'Week 24', 'description': 'CGI-S is a single item used to measure the clinician\'s impression of the current severity of the patient\'s essential tremor. The measure uses a 5-point rating scale where "0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe."'}, {'measure': 'Change From Baseline in Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Week 24', 'description': "PGI-S is a single item used to measure the participant's impression of severity of their essential tremor symptoms. The measure uses a 5-point rating scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe."}, {'measure': 'Change From Baseline in Essential Tremor Rating Assessment (TETRAS UL) Score', 'timeFrame': 'Week 24', 'description': 'TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor during three maneuvers: forward horizontal reach posture, lateral "wing beating" posture, and finger-nose-finger testing. Each maneuver is scored from 0 to 4, with 1 indicating a tremor amplitude that is "barely visible" and 4 indicating a tremor amplitude that is \\>= 20 cm.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper Limb Essential Tremor', 'UL ET', 'BOTOX', 'Botulinum Toxin Type A'], 'conditions': ['Upper Limb Essential Tremor (UL ET)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M21-471', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated.\n\nBOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America.\n\nParticipants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol.\n* TREDS-Revised Scale (1-4 scale, whole numbers) unilateral score of \\>= 3 for the Tremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb.\n* TETRAS activities of daily living (ADL) (recorded on a 0-4 scale, whole numbers) minimum score of \\>= 3 on any of the 5 unilateral items; no more than a single item score of \\<=1 among the 5 unilateral items in the dominant limb.\n* At least one of the following criteria must also be met:\n\n * TETRAS UL score (0-4 scale, with 0.5 increments) of \\> 2 in the dominant limb on at least one of the 3 maneuvers OR\n * TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) of \\> 2 in the dominant limb\n\nExclusion Criteria:\n\n* Any uncontrolled clinically significant medical condition other than the one under study.\n* Any medical condition that may put the participant at increased risk with exposure to BOTOX Purified Neurotoxin Complex.'}, 'identificationModule': {'nctId': 'NCT05216250', 'briefTitle': 'Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Upper Limb Essential Tremor', 'orgStudyIdInfo': {'id': 'M21-471'}, 'secondaryIdInfos': [{'id': '2021-002191-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOTOX/BOTOX Unilateral', 'description': 'Participants will receive BOTOX in Cycle 1 and Cycle 2 and unilateral BOTOX in Cycle 3', 'interventionNames': ['Biological: BOTOX']}, {'type': 'EXPERIMENTAL', 'label': 'BOTOX/BOTOX Bilateral', 'description': 'Participants will receive BOTOX in Cycle 1 and Cycle 2 and bilateral BOTOX in Cycle 3', 'interventionNames': ['Biological: BOTOX']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/BOTOX Unilateral', 'description': 'Participants will receive placebo in Cycle 1 and Cycle 2 followed by unilateral BOTOX in Cycle 3.', 'interventionNames': ['Biological: BOTOX', 'Drug: Placebo for BOTOX']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/BOTOX Bilateral', 'description': 'Participants will receive placebo in Cycle 1 and Cycle 2 followed by bilateral BOTOX in Cycle 3.', 'interventionNames': ['Biological: BOTOX', 'Drug: Placebo for BOTOX']}], 'interventions': [{'name': 'BOTOX', 'type': 'BIOLOGICAL', 'otherNames': ['Botulinum Toxin Type A'], 'description': 'Intramuscular injection', 'armGroupLabels': ['BOTOX/BOTOX Bilateral', 'BOTOX/BOTOX Unilateral', 'Placebo/BOTOX Bilateral', 'Placebo/BOTOX Unilateral']}, {'name': 'Placebo for BOTOX', 'type': 'DRUG', 'description': 'Intramuscular injection', 'armGroupLabels': ['Placebo/BOTOX Bilateral', 'Placebo/BOTOX Unilateral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244-5700', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona /ID# 239781', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University /ID# 230905', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '80045-2527', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Anschutz Medical Campus /ID# 239869', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Institute for Clinical Research /ID# 238404', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32034-4779', 'city': 'Fernandina Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Clinical Research Specialists /ID# 240897', 'geoPoint': {'lat': 30.66968, 'lon': -81.46259}}, {'zip': '32205-8275', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Clinical Research Specialists /ID# 240471', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32803-1839', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Charter Research - Winter Park /ID# 241568', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34952-7539', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'CDC Research Institute LLC /ID# 242744', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '30329-2206', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University / Emory Brain Health Center /ID# 231911', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030-2627', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Accel Research Site-NeuroStudies /ID# 239881', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Univ Kansas Med Ctr /ID# 231166', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66211-1363', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Institute of Research /ID# 231623', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '02111-1552', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center /ID# 239929', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Hospital & Medical Center /ID# 233232', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '49201-1852', 'city': 'Jackson', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health Medical Center - 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Falls Church /ID# 233545', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '53228-1321', 'city': 'Greenfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gamma Therapeutic Center /ID# 232547', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic - Marshfield /ID# 233191', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': 'V6T 1Z9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Coastal Health Authority - University of British Columbia /ID# 240356', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3S 1N2', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Centricity Research /ID# 240587', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital /ID# 231587', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 3T2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Genge Partners /ID# 251546', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing, please refer to the link below.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}