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NCT03136341 · ClinicalTrials.gov registry record · Phase 4
A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor
A Phase 4 study of Tremor, Limb, sponsored by David M. Simpson.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03136341: Recruiting Phase 4 study of Tremor, Limb, sponsored by David M. Simpson.
NCT03136341 is a Phase 4 study of Tremor, Limb that is actively recruiting participants, run by David M. Simpson. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03136341, a Phase 4 study of Tremor, Limb, is actively recruiting participants, sponsored by David M. Simpson.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The principal outcome measure will be patient's impression of change using visual analog scale. Visual Analog Scale (VAS) 100 point scale from 0 (no improvement) to 100 (normal use).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Abobotulinum toxin A
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-12-04 |
| Est. Completion | 2022-12 |
| Phase | Phase 4 |
What NCT03136341 shows while recruiting
NCT03136341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Tremor, Limb appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03136341 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03136341 about?
NCT03136341 is a clinical study titled "A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor". 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...
What is the current status of trial NCT03136341?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2018-12-04. Estimated completion is 2022-12.
What conditions does trial NCT03136341 study?
This clinical trial studies the following conditions: Tremor, Limb.
What interventions are being tested in trial NCT03136341?
The interventions under investigation include: Placebo (OTHER), Abobotulinum toxin A (DRUG).
Who is sponsoring clinical trial NCT03136341?
This trial is sponsored by David M. Simpson, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03136341 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tremor, Limb
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03136341's enrollment target sits among peer trials
25 1669th of 2000 higher than 303 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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