Using Dysport to treat 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

This study is testing if Dysport injections can help people with task-dependent upper limb tremors improve their daily functioning.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT03136341 on ClinicalTrials.gov

What this trial studies

This pilot trial explores the use of Abobotulinum Toxin A (Dysport) to treat patients with task-dependent upper limb tremor, a condition that significantly affects daily functioning. The study will involve 25 participants who will receive either the treatment or a placebo, with their motor performance and disability assessed through blinded video analysis. The goal is to evaluate the efficacy and tolerability of the injections and to gather data for future larger trials.

Who should consider this trial

Good fit: Ideal candidates are patients with task-dependent essential tremor in the upper limb who can perform specific functional tasks.

Not a fit: Patients without tremor during the study's functional tasks or those with insufficient tremor amplitude will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve motor performance and quality of life for patients suffering from task-dependent upper limb tremor.

How similar studies have performed: While few studies have quantified the effects of botulinum toxin on tremor, this approach is exploratory and may provide new insights into treatment efficacy.

Eligibility criteria

Inclusion Criteria:

* Patients with task-dependent essential tremor in upper limb. Tremor is present during at least one of the study functional tasks i. pointing task (touch between nose and a pen held 2 ft. in front. ii. pouring task (cup: pouring water out/in). iii. feeding task (weighted fork from plate on table to mouth). iv. string instrument bowing or holding instrument in static position. v. computer mouse (simple vertical or horizontal movements).
* Patients must be capable of performing informed consent.
* Patients on stable medications for treatment of task-dependent essential tremor for 1 month prior to study entry and maintain them throughout the study.
* Patients previously treated with BoNT of any type must have occurred no sooner than 12 weeks prior to study entry.

Exclusion Criteria:

* Patients with no presence of tremor during study functional tasks.
* Presence of tremor during the functional task is below minimum amplitude required to be considered for injection based upon investigator's clinical judgment.
* Patients with unstable medical conditions or psychiatric conditions.
* Patients with a medical condition that precludes them from receiving BoNT injections.
* Pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study.
* Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure to other than the listed tremorogenic or potentially tremorogenic drugs is allowed only if, in the opinion of the investigator, this will not interfere with the study drug evaluations.

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: David M Simpson, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Mary-Catherine George

Conditions: Tremor, Limb, Upper Limb, Tremor, task-dependent