Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-27 @ 3:23 PM
Study NCT ID:
NCT01786603
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2012-11-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031967', 'term': 'rasagiline'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbarohn@kumc.edu', 'phone': '913-945-9944', 'title': 'Dr. Richard Barohn', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 28, 'seriousNumAtRisk': 60, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 15, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear and Labyrinth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 49, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, Poisoning, Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 25, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laboratory Abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and Nutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 20, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical/Medical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'ALS Functional Rating Scale-Revised (ALSFRS-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-1.22', 'upperLimit': '-0.77'}, {'value': '-1.26', 'groupId': 'OG001', 'lowerLimit': '-1.64', 'upperLimit': '-0.87'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'ALS Functional Rating Scale-Revised (ALSFRS-R) Difference from Baseline to Month 12', 'description': 'Difference in ALS Functional Rating Scale - Revised (ALSFRS-R) score. The ALSFRS-R is an ordinal rating scale that assesses 12 functional activities. Each activity is scored between 0-4, with a total score ranging from 48 (normal function) to 0 (no function).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vital Capacity (VC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.24', 'groupId': 'OG000', 'lowerLimit': '-2.86', 'upperLimit': '-1.64'}, {'value': '-2.48', 'groupId': 'OG001', 'lowerLimit': '-3.54', 'upperLimit': '-1.43'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Vital Capacity Change from Baseline to Month 12', 'description': 'Determine if decline in vital capacity is slower in participants taking 2 mg rasagiline than controls.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-0.13', 'upperLimit': '-0.06'}, {'value': '-0.12', 'groupId': 'OG001', 'lowerLimit': '-0.18', 'upperLimit': '-0.05'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Quality of Life Change from Baseline to Month 12', 'description': 'Participants completed the single-item ALSQOL (ALS Quality of Life) which asks participants to rank their global quality of life, considering all parts of their lives - physical, emotional, social, spiritual and financial - in the last 7 days and rate on a scale of 0 (very bad) to 10 (excellent).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse Events from Baseline to Month 12', 'description': 'Determine if participants on rasagiline 2 mg had a different safety profile than patients not on rasagiline. Adverse event information to be collected from date of enrollment until end of study participation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Survival Status Between Study Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Survival status at Month 12', 'description': 'Determine if there is a difference in survival between participants on rasagiline than patients not on rasagiline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect of Study Drug on Apoptosis Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.019', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Apoptosis Marker change from Baseline to Month 12', 'description': 'Effect of rasagiline on the apoptosis markers (Annexin V stain) in participants with ALS. Assessed at baseline, month 6, and month 12; change from baseline to month 12 reported. Extra time point was not a pre-specified Primary or Secondary Outcome Measure.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect of Study Drug on Oxidative Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '2.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Oxidative Stress change from Baseline to Month 12', 'description': 'Determine if oxygen radical antioxidant capacity is targeted by rasagiline in participants with ALS. Assessed at baseline, month 6, and month 12; change from baseline to month 12 reported. Extra time point was not a pre-specified Primary or Secondary Outcome Measure.', 'unitOfMeasure': 'pmole/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician decision to withdraw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.\n\nRasagiline: Rasagiline 2mg once a day for 12 months.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.\n\nPlacebo: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '57.5', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '57.95', 'spread': '9.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2012-11-28', 'resultsFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2013-02-05', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-14', 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ALS Functional Rating Scale-Revised (ALSFRS-R)', 'timeFrame': 'ALS Functional Rating Scale-Revised (ALSFRS-R) Difference from Baseline to Month 12', 'description': 'Difference in ALS Functional Rating Scale - Revised (ALSFRS-R) score. The ALSFRS-R is an ordinal rating scale that assesses 12 functional activities. Each activity is scored between 0-4, with a total score ranging from 48 (normal function) to 0 (no function).'}], 'secondaryOutcomes': [{'measure': 'Change in Vital Capacity (VC)', 'timeFrame': 'Vital Capacity Change from Baseline to Month 12', 'description': 'Determine if decline in vital capacity is slower in participants taking 2 mg rasagiline than controls.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Quality of Life Change from Baseline to Month 12', 'description': 'Participants completed the single-item ALSQOL (ALS Quality of Life) which asks participants to rank their global quality of life, considering all parts of their lives - physical, emotional, social, spiritual and financial - in the last 7 days and rate on a scale of 0 (very bad) to 10 (excellent).'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Adverse Events from Baseline to Month 12', 'description': 'Determine if participants on rasagiline 2 mg had a different safety profile than patients not on rasagiline. Adverse event information to be collected from date of enrollment until end of study participation.'}, {'measure': 'Difference in Survival Status Between Study Groups', 'timeFrame': 'Survival status at Month 12', 'description': 'Determine if there is a difference in survival between participants on rasagiline than patients not on rasagiline'}, {'measure': 'Effect of Study Drug on Apoptosis Markers', 'timeFrame': 'Apoptosis Marker change from Baseline to Month 12', 'description': 'Effect of rasagiline on the apoptosis markers (Annexin V stain) in participants with ALS. Assessed at baseline, month 6, and month 12; change from baseline to month 12 reported. Extra time point was not a pre-specified Primary or Secondary Outcome Measure.'}, {'measure': 'Effect of Study Drug on Oxidative Stress', 'timeFrame': 'Oxidative Stress change from Baseline to Month 12', 'description': 'Determine if oxygen radical antioxidant capacity is targeted by rasagiline in participants with ALS. Assessed at baseline, month 6, and month 12; change from baseline to month 12 reported. Extra time point was not a pre-specified Primary or Secondary Outcome Measure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis (ALS)']}, 'descriptionModule': {'briefSummary': "ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. Motor neurons are responsible for sending signals to muscles in our bodies to trigger movement. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS.\n\nRasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics, but the effectiveness of rasagiline for patients with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's disease.\n\nRasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration (FDA) and is investigational. Investigational drugs are studied to find out if they are safe and effective in the treatment of diseases or conditions.\n\nBy doing this study, researchers hope to learn if rasagiline is safe and slows disease progression in patients with ALS.\n\nFunding Source - FDA OOPD (FDA Orphan Products Division).", 'detailedDescription': 'The study is a phase II, double-blind, placebo-controlled, multicenter study of rasagiline 2mg/day. Subjects will be assigned to either active agent or placebo (3:1) for twelve months. Subjects will undergo outpatient evaluations at screening, baseline, and months 1, 2, 4, 6, 8, 10 and 12 and telephone assessments at months 3, 5, 7 and 9. There will be a close-out phone call 30 days post month 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).\n2. 21 to 80 years of age inclusive.\n3. VC greater or equal to 75% of predicted at screening and baseline.\n4. Onset of weakness within 2 years prior to enrollment.\n5. If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.\n6. Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test.\n7. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).\n\nExclusion criteria\n\n1. Requirement for tracheotomy ventilation or non-invasive ventilation for \\> 23 hours per day.\n2. Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.\n3. Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphene, flexeril.\n4. Patients on fluoxetine or fluvoxamine.\n5. Patients taking amitriptyline \\> 50 mg/d, trazodone and sertraline \\> 100 mg/d, citalopram \\> 20 mg/d or paroxetine \\> 30 mg/d.\n6. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).\n7. Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.\n8. Has a diaphragm pacing device or plan on obtaining a diaphragm pacing device during the course of the study.\n9. History of renal disease.\n10. History of liver disease.\n11. Current pregnancy or lactation.\n12. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.\n13. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.\n14. Vital Capacity (VC) \\< 75% of predicted.\n15. Receipt of any investigational drug within the past 30 days.\n16. Women with the potential to become pregnant who are not practicing effective birth control.\n17. Poorly controlled hypertensive subjects or resting systolic blood pressure (SBP) \\> 160 mmHg and/or diastolic (DBP) \\> 95 mmHg.\n18. Use of BiPAP at screening.'}, 'identificationModule': {'nctId': 'NCT01786603', 'briefTitle': 'Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis', 'orgStudyIdInfo': {'id': '12312'}, 'secondaryIdInfos': [{'id': 'R01FD003739', 'link': 'https://reporter.nih.gov/quickSearch/R01FD003739', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rasagiline', 'description': 'Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months.', 'interventionNames': ['Drug: Rasagiline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rasagiline', 'type': 'DRUG', 'otherNames': ['Azilect'], 'description': 'Rasagiline 2mg once a day for 12 months.', 'armGroupLabels': ['Rasagiline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (looks like study drug but has no active ingredients) once a day for 12 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Neurological Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92868', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Richard Barohn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Richard Barohn, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gertrude and Dewey Zeigler Professor of Neurology and Chair', 'investigatorFullName': 'Richard Barohn, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}