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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00208091 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia
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Scientific title:
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An Open Label Evaluation of MIDI to Quantify Performance Change in Subjects With Musician's Dystonia After Treatment With Botulinum Toxin Type B (Myobloc ®). |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00208091 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Seth Pullman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University Medical Center, Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Focal, task-specific dystonia clinically determined to be the result of a high level
of musical skill and intensive performance history
Exclusion Criteria:
- Neurological disorders other than dystonia
- Patients who are clinically depressed, demented or otherwise unable to perform
appropriately or sit through 1 hour of testing
- Patients who have undergone pallidotomy, thalamotomy or deep brain stimulator
implantations
- Patients who have who recently have taken medications with extrapyramidal or
tremorogenic side effects
Age minimum:
25 Years
Age maximum:
69 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Focal Dystonia
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Intervention(s)
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Drug: Botulinum toxin, type B
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Primary Outcome(s)
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Note Errors (Related to Errors in Duration)
[Time Frame: Baseline and 6 weeks post-injection]
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Note Errors (Related to Errors in Loudness)
[Time Frame: Baseline and 6 weeks post-injection]
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Secondary Outcome(s)
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Subjective Assessment Ratings of Change
[Time Frame: Baseline to 6 weeks after injection]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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