Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT02107261
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2014-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'C566973', 'term': 'Dystonia, Focal, Task-Specific'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545476', 'term': 'incobotulinumtoxinA'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.simpson@mssm.edu', 'phone': '2122418748', 'title': 'David Simpson, M.D.', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'matching placebo injection', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Incobotulinum Toxin Injection', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 7, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physician Global Perception of Change - Blinded Rater 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'Incobotulinum Toxin Injection', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at visit 4 (week 8)', 'description': 'The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected for one participant. Data results for Week 8 before crossover treatment.'}, {'type': 'PRIMARY', 'title': 'Physician Global Perception of Change - Blinded Rater 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'Incobotulinum Toxin Injection', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Minimal Improved', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Minimal Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at visit 4 (week 8)', 'description': 'The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected for one participant. Data results for Week 8 before crossover treatment.'}, {'type': 'PRIMARY', 'title': 'Rating of Overall Musical Performance - Blinded Rater 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'XEOMIN', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'classes': [{'title': '+3 Very much improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '+2 Much improved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '+1 Minimally improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '0 No change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '-1 Minimal worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '-2 Much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-3 Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Rating of overall musical performance based on comparison to baseline video at week 8.\n\nRating from +3, very much improved to -3, very much worse. Higher score indicates more improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected for one participant. Data results for Week 8 before crossover treatment.'}, {'type': 'PRIMARY', 'title': 'Rating of Overall Musical Performance - Blinded Rater 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'Incobotulinum Toxin Injection', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'classes': [{'title': '+3 Very much improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '+2 Much Improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '+1 Minimally Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '0 No Change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '-1 Minimally Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '-2 Much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-3 Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and week 8', 'description': 'Rating of overall musical performance based on comparison to baseline video at week 8.\n\nBest Overall Musical Performance on 7 point scale from +3 Very much improved to -3 Very much worse. Higher score indicates more improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected for one participant. Data results for Week 8 before crossover treatment.'}, {'type': 'PRIMARY', 'title': 'Quantitative MIDI Analysis Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'Incobotulinum Toxin Injection', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'timeFrame': 'baseline at 24 weeks', 'description': 'The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative Musical Instrument Digital Interface (MIDI) analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected at 24 weeks'}, {'type': 'PRIMARY', 'title': 'Blinded High Speed Video Analysis Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'Incobotulinumtoxin A', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'timeFrame': 'baseline and at 24 weeks', 'description': 'The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative MIDI analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected at 24 weeks'}, {'type': 'SECONDARY', 'title': 'Change in Perceived Stress Scale (PSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'XEOMIN', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.429', 'spread': '0.864', 'groupId': 'OG000'}, {'value': '-0.5031', 'spread': '0.946', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Patient reported outcomes measured by questionnaires that address adverse events and the impact of quality of life using the perceived stress scale. A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress. the more often the person perceives stress Change in PSS at week 8 compared to baseline', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data results for Week 8 before crossover treatment.'}, {'type': 'SECONDARY', 'title': 'Change in Medical Research Council (MRC) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'XEOMIN', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'classes': [{'title': 'Right FDP dig 2', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.0655', 'groupId': 'OG000'}, {'value': '-0.087', 'spread': '0.0654', 'groupId': 'OG001'}]}]}, {'title': 'R Lumb dig 4', 'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.0493', 'groupId': 'OG000'}, {'value': '-0.1190', 'spread': '0.0492', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Motor strength using a dynamometer of the finger/wrist/elbow flexors to document any treatment induced weakness.\n\nScale from 0-4, higher score indicates poorer health outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data results for Week 8 before crossover treatment.'}, {'type': 'SECONDARY', 'title': 'Change in Motor Strength Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching placebo injection'}, {'id': 'OG001', 'title': 'XEOMIN', 'description': 'Incobotulinumtoxin A used on average doses between 10U and 30 Units per subject, but at no time did any subject receive over 100 Units. Each study visit, the assessing physician selected the muscles and the amounts of medication to be injected.'}], 'classes': [{'title': 'DYN pnch 4 max', 'categories': [{'measurements': [{'value': '0.679', 'spread': '0.5954', 'groupId': 'OG000'}, {'value': '-3.037', 'spread': '0.629', 'groupId': 'OG001'}]}]}, {'title': 'DYN pnch 4 avg', 'categories': [{'measurements': [{'value': '1.065', 'spread': '0.5688', 'groupId': 'OG000'}, {'value': '-2.323', 'spread': '0.5951', 'groupId': 'OG001'}]}]}, {'title': 'DYN pnch 3 max', 'categories': [{'measurements': [{'value': '0.5570', 'spread': '0.7079', 'groupId': 'OG000'}, {'value': '-2.905', 'spread': '0.7522', 'groupId': 'OG001'}]}]}, {'title': 'DYN pnch 3 Avg', 'categories': [{'measurements': [{'value': '1.1440', 'spread': '0.6354', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '0.6762', 'groupId': 'OG001'}]}]}, {'title': 'Grip max', 'categories': [{'measurements': [{'value': '3.084', 'spread': '4.6889', 'groupId': 'OG000'}, {'value': '-25.04', 'spread': '4.9933', 'groupId': 'OG001'}]}]}, {'title': 'Grip avg', 'categories': [{'measurements': [{'value': '4.944', 'spread': '4.721', 'groupId': 'OG000'}, {'value': '-22.172', 'spread': '4.9974', 'groupId': 'OG001'}]}]}, {'title': 'FF D2-3', 'categories': [{'measurements': [{'value': '19.526', 'spread': '7.1284', 'groupId': 'OG000'}, {'value': '-4.423', 'spread': '6.5695', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Motor strength tested using a dynamometer to document any weakness the treatment may produce as compared to the baseline visit and 8 weeks.\n\nDynamometer (DYN) - is a mechanical device that measures the pounds of force that a muscle exerts, Grip - a device that measures grip strength, and finger flexors digit 2 and 3 (FF d2-3). These measures are the amount of lbs of force exert. The higher number is the highest exerted out of 3 tries.', 'unitOfMeasure': 'lbs of force exert', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data results for Week 8 before crossover treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Then Botulinum Toxin', 'description': 'Placebo dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Incobotulinumtoxin A first dose, with boosters at 2 week and week 4.'}, {'id': 'FG001', 'title': 'Incobotulinumtoxin A Then Placebo', 'description': 'Incobotulinumtoxin A dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Placebo first dose, with boosters at 2 week and week 4.'}], 'periods': [{'title': 'Cycle 1: Week 1-4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout: Weakness Back to Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Cycle 2: Week 12-15', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Then Botulinum Toxin', 'description': 'Placebo dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Incobotulinumtoxin A first dose, with boosters at 2 week and week 4.'}, {'id': 'BG001', 'title': 'Botulinum Toxin Then Placebo', 'description': 'Incobotulinumtoxin A dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Placebo first dose, with boosters at 2 week and week 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.68', 'groupId': 'BG000', 'lowerLimit': '38.04', 'upperLimit': '56.71'}, {'value': '49.66', 'groupId': 'BG001', 'lowerLimit': '37.76', 'upperLimit': '63.00'}, {'value': '50.2', 'groupId': 'BG002', 'lowerLimit': '37.76', 'upperLimit': '63.00'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-22', 'size': 318434, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-03T15:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2014-03-26', 'resultsFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-19', 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician Global Perception of Change - Blinded Rater 1', 'timeFrame': 'at visit 4 (week 8)', 'description': 'The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.'}, {'measure': 'Physician Global Perception of Change - Blinded Rater 2', 'timeFrame': 'at visit 4 (week 8)', 'description': 'The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.'}, {'measure': 'Rating of Overall Musical Performance - Blinded Rater 1', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Rating of overall musical performance based on comparison to baseline video at week 8.\n\nRating from +3, very much improved to -3, very much worse. Higher score indicates more improvement.'}, {'measure': 'Rating of Overall Musical Performance - Blinded Rater 2', 'timeFrame': 'baseline and week 8', 'description': 'Rating of overall musical performance based on comparison to baseline video at week 8.\n\nBest Overall Musical Performance on 7 point scale from +3 Very much improved to -3 Very much worse. Higher score indicates more improvement.'}, {'measure': 'Quantitative MIDI Analysis Comparison', 'timeFrame': 'baseline at 24 weeks', 'description': 'The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative Musical Instrument Digital Interface (MIDI) analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.'}, {'measure': 'Blinded High Speed Video Analysis Comparison', 'timeFrame': 'baseline and at 24 weeks', 'description': 'The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative MIDI analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in Perceived Stress Scale (PSS)', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Patient reported outcomes measured by questionnaires that address adverse events and the impact of quality of life using the perceived stress scale. A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress. the more often the person perceives stress Change in PSS at week 8 compared to baseline'}, {'measure': 'Change in Medical Research Council (MRC) Scale', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Motor strength using a dynamometer of the finger/wrist/elbow flexors to document any treatment induced weakness.\n\nScale from 0-4, higher score indicates poorer health outcomes.'}, {'measure': 'Change in Motor Strength Comparison', 'timeFrame': 'baseline and at 8 weeks', 'description': 'Motor strength tested using a dynamometer to document any weakness the treatment may produce as compared to the baseline visit and 8 weeks.\n\nDynamometer (DYN) - is a mechanical device that measures the pounds of force that a muscle exerts, Grip - a device that measures grip strength, and finger flexors digit 2 and 3 (FF d2-3). These measures are the amount of lbs of force exert. The higher number is the highest exerted out of 3 tries.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Musician's Dystonia"], 'conditions': ['Dystonia']}, 'referencesModule': {'references': [{'pmid': '18785647', 'type': 'BACKGROUND', 'citation': 'Jankovic J, Ashoori A. Movement disorders in musicians. Mov Disord. 2008 Oct 30;23(14):1957-65. doi: 10.1002/mds.22255.'}, {'pmid': '15668411', 'type': 'BACKGROUND', 'citation': "Pullman SL, Hristova AH. Musician's dystonia. Neurology. 2005 Jan 25;64(2):186-7. doi: 10.1212/01.WNL.0000157497.08500.c1. No abstract available."}, {'pmid': '12945651', 'type': 'BACKGROUND', 'citation': 'Altenmuller E. Focal dystonia: advances in brain imaging and understanding of fine motor control in musicians. Hand Clin. 2003 Aug;19(3):523-38, xi. doi: 10.1016/s0749-0712(03)00043-x.'}, {'pmid': '11746620', 'type': 'BACKGROUND', 'citation': "Frucht SJ, Fahn S, Greene PE, O'Brien C, Gelb M, Truong DD, Welsh J, Factor S, Ford B. The natural history of embouchure dystonia. Mov Disord. 2001 Sep;16(5):899-906. doi: 10.1002/mds.1167."}, {'pmid': '7569982', 'type': 'BACKGROUND', 'citation': 'Elbert T, Pantev C, Wienbruch C, Rockstroh B, Taub E. Increased cortical representation of the fingers of the left hand in string players. Science. 1995 Oct 13;270(5234):305-7. doi: 10.1126/science.270.5234.305.'}, {'pmid': '12042882', 'type': 'BACKGROUND', 'citation': "Munte TF, Altenmuller E, Jancke L. The musician's brain as a model of neuroplasticity. Nat Rev Neurosci. 2002 Jun;3(6):473-8. doi: 10.1038/nrn843."}, {'pmid': '22524368', 'type': 'BACKGROUND', 'citation': "Altenmuller E, Baur V, Hofmann A, Lim VK, Jabusch HC. Musician's cramp as manifestation of maladaptive brain plasticity: arguments from instrumental differences. Ann N Y Acad Sci. 2012 Apr;1252:259-65. doi: 10.1111/j.1749-6632.2012.06456.x."}, {'pmid': '16924027', 'type': 'BACKGROUND', 'citation': "Schmidt A, Jabusch HC, Altenmuller E, Hagenah J, Bruggemann N, Hedrich K, Saunders-Pullman R, Bressman SB, Kramer PL, Klein C. Dominantly transmitted focal dystonia in families of patients with musician's cramp. Neurology. 2006 Aug 22;67(4):691-3. doi: 10.1212/01.wnl.0000230148.00035.f9."}, {'pmid': '20795373', 'type': 'BACKGROUND', 'citation': 'Altenmuller E, Jabusch HC. Focal dystonia in musicians: phenomenology, pathophysiology, triggering factors, and treatment. Med Probl Perform Art. 2010 Mar;25(1):3-9.'}, {'pmid': '15668436', 'type': 'BACKGROUND', 'citation': "Schuele S, Jabusch HC, Lederman RJ, Altenmuller E. Botulinum toxin injections in the treatment of musician's dystonia. Neurology. 2005 Jan 25;64(2):341-3. doi: 10.1212/01.WNL.0000149768.36634.92."}, {'pmid': '8929169', 'type': 'BACKGROUND', 'citation': 'Pullman SL, Greene P, Fahn S, Pedersen SF. Approach to the treatment of limb disorders with botulinum toxin A. Experience with 187 patients. Arch Neurol. 1996 Jul;53(7):617-24. doi: 10.1001/archneur.1996.00550070055012.'}, {'pmid': '23884039', 'type': 'BACKGROUND', 'citation': "Peterson DA, Berque P, Jabusch HC, Altenmuller E, Frucht SJ. Rating scales for musician's dystonia: the state of the art. Neurology. 2013 Aug 6;81(6):589-98. doi: 10.1212/WNL.0b013e31829e6f72. Epub 2013 Jul 24."}, {'pmid': '23814536', 'type': 'BACKGROUND', 'citation': "Chang FC, Frucht SJ. Motor and Sensory Dysfunction in Musician's Dystonia. Curr Neuropharmacol. 2013 Jan;11(1):41-7. doi: 10.2174/157015913804999531."}]}, 'descriptionModule': {'briefSummary': "The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®). Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves, inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be critical for the musical professional to continue his or her career. With the use of EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize the individual muscles that are affected in this condition with great accuracy. Prior studies have shown that BoNT injections produce beneficial effects in forearm muscles, and less effect in shoulder or proximal arm muscles.\n\nPossible risks in treating patients with BoNT include excessive weakness of the injected muscles. The drug may also affect non-targeted muscles. However these risks will be minimized during the screening period by carefully targeting the affected muscles and by administering low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks after the primary injection date) if the initial injection was insufficient to produce sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of the targeted muscle."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with focal task-specific dystonia of one or both hands, selectively triggered by performance on a musical instrument.\n* Patients must have been evaluated by Dr. Frucht at the Movement Disorders Division of Mount Sinai Medical Center as part of their clinical care.\n* Patients whose performance on an instrument is directly linked to their occupation.\n* Patients must be between the ages of 18 and 80.\n* Impairment in musical performance must be visible and demonstrable.\n\nExclusion Criteria:\n\n* Patients whose dystonia is not severe enough to interfere with musical performance in the opinion of a skilled examiner.\n* Patients with unstable medical conditions or psychiatric conditions.\n* Patients with a medical condition that precludes them from receiving BoNT injections.'}, 'identificationModule': {'nctId': 'NCT02107261', 'briefTitle': "Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand", 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': "A Placebo-Controlled, Double-Blind, Randomized, Cross Over Pilot Study Of The Efficacy And Tolerability Of Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand", 'orgStudyIdInfo': {'id': 'GCO 13-1679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo Then Botulinum Toxin', 'description': 'Placebo dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Incobotulinumtoxin A first dose, with boosters at 2 week and week 4.', 'interventionNames': ['Drug: incobotulinumtoxin A', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Incobotulinumtoxin A Then Placebo', 'description': 'Incobotulinumtoxin A dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Placebo first dose, with boosters at 2 week and week 4.', 'interventionNames': ['Drug: incobotulinumtoxin A', 'Drug: Placebo']}], 'interventions': [{'name': 'incobotulinumtoxin A', 'type': 'DRUG', 'otherNames': ['Xeomin'], 'description': 'Incobotulinumtoxin A is being used on average doses between 10U and 30 Units per subject, but at no time will any subject receive over 100 Units. Each study visit, the assessing physician will select the muscles and the amounts of medication to be injected.', 'armGroupLabels': ['Incobotulinumtoxin A Then Placebo', 'Placebo Then Botulinum Toxin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['Incobotulinumtoxin A Then Placebo', 'Placebo Then Botulinum Toxin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Steven Frucht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}, {'name': 'David M Simpson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David M. Simpson', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}