Actively Recruiting
A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor
Led by David M. Simpson · Updated on 2021-02-25
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
D
David M. Simpson
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with task-dependent essential tremor in upper limb present during at least one specified functional task
- Ability to provide informed consent
- Stable medication for task-dependent essential tremor for at least 1 month prior to study entry and maintained throughout the study
- Previous botulinum toxin treatment must have been at least 12 weeks before study entry
You will not qualify if you...
- No tremor present during study functional tasks
- Tremor amplitude below minimum required for injection based on investigator judgment
- Unstable medical or psychiatric conditions
- Medical conditions preventing botulinum toxin injections
- Pregnant women or premenopausal women unwilling to use contraception during the study
- Use of lithium, valproic acid, amiodarone, typical or atypical neuroleptics
- Use of other tremorogenic drugs unless approved by investigator as not interfering with study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Mary-Catherine George
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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