NCT03136341

A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor

A Placebo-controlled, Double-blind, Randomized, Cross Over Pilot Study of the Efficacy and Tolerability of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: David M. Simpson · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tremor, Limb

Interventions

Type	Name	Description
DRUG	Abobotulinum toxin A	Dosing will be determined at each study visit based upon muscles involved
OTHER	Placebo	Dosing will be determined at each study visit based upon muscles involved

Timeline

• Start date: 2018-12-04
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2017-05-02
• Last updated: 2021-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study