Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID03136341

A Placebo-controlled, Double-blind, Randomized, Crossover Pilot Study of Abobotulinum Toxin A (Dysport) for Task-dependent Upper Limb Tremor

Led by David M. Simpson · Updated on 2021-02-25

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

D

David M. Simpson

Lead Sponsor

I

Ipsen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Abobotulinum toxin A (Dysport) in adults aged 18 to 80 years who have task-dependent essential tremor affecting the upper limb. This pilot study aims to refine ways to measure improvements in motor skills and disability using video analysis, and to assess the effects and tolerability of Dysport injections. The study also seeks to gather data that will help design a larger future clinical trial. The study uses a randomized, double-blind, placebo-controlled, crossover design where participants receive Dysport injections and placebo injections during different periods. The dose of Dysport is adjusted at each visit based on the muscles involved. Participants perform specific functional tasks to assess tremor severity, including pointing, pouring, feeding, string instrument playing, or computer mouse use. Participants will be monitored through patient and physician impressions of change at 6 and 18 weeks after injections. The study tracks motor performance and disability improvements via blinded video analysis. Safety and tolerability of the injections are also evaluated. The total duration includes multiple visits to assess the effects of both Dysport and placebo treatments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with task-dependent essential tremor in the upper limb during at least one functional task such as pointing, pouring, feeding, string instrument bowing or holding, or computer mouse use.
  • Able to provide informed consent.
  • On stable medications for task-dependent essential tremor for at least 1 month before study entry and remain stable throughout the study.
  • Previous botulinum toxin treatment must have been at least 12 weeks before study entry.
Not Eligible

You will not qualify if you...

  • No tremor present during study functional tasks.
  • Tremor amplitude below the minimum required for injection per investigator judgment.
  • Unstable medical or psychiatric conditions.
  • Medical conditions preventing botulinum toxin injections.
  • Pregnant women or premenopausal women unwilling to use contraceptives during the study.
  • Use of lithium, valproic acid, amiodarone, typical or atypical neuroleptics that may interfere with study drug evaluation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - At least 1 month

Participants maintain stable medications for task-dependent essential tremor for at least 1 month before starting treatment.

1 baseline visit

Treatment

Duration - 18 weeks

Participants receive either Abobotulinum toxin A or placebo injections with dosing based on muscles involved in the task-dependent upper limb tremor.

Multiple visits over 18 weeks for dosing and assessment

Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

Loading map...

Research Team

M

Mary-Catherine George

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

The convergence of medicine and neurotoxins: a focus on botulinum toxin type A and its application in aesthetic medicine--a global, evidence-based botulinum toxin consensus education initiative: part II: incorporating botulinum toxin into aesthetic clinical practice.

Jean Carruthers, Nathalie Fournier, Martina Kerscher...

https://pubmed.ncbi.nlm.nih.gov/23458295