A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor
Part of paid clinical trials in New York, New York.
- Sponsor
- David M. Simpson
- Study ID
- NCT03136341
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Tremor, Limb
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Abobotulinum toxin A — DRUGDosing will be determined at each study visit based upon muscles involved
- Placebo — OTHERDosing will be determined at each study visit based upon muscles involved
Study Details
Task-dependent upper limb tremor is a disorder that frequently impairs patients' function and quality of life. Few studies exist that quantify the improvements in motor performance and disability with botulinum toxin (injections). The study team aims to perform an exploratory pilot trial using toxin Type A (Dysport) in 25 patients with task-dependent upper limb tremor, to refine quantitative measures of performance using blinded video analysis, demonstrate efficacy and tolerability of injections, and provide power calculations for a potential future multi-centered double blinded clinical trial.
Key Dates
- Start date
- Dec 4, 2018
- Status verified
- Feb 2021
- Primary completion
- Dec 31, 2022
- Completion
- Dec 31, 2022
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Abobotulinum toxin A
- Placebo Comparator: Placebo
Primary Outcome Measure
Patient's Impression of Change [ Time Frame: Week 6 ]
Central Contacts
- Mary-Catherine George212-241-0784
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | David M Simpson, MD (PRINCIPAL_INVESTIGATOR) |
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