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

Last updated: February 23, 2021
Sponsor: David M. Simpson
Overall Status: Active - Recruiting

Phase

4

Condition

Dystonia

Treatment

N/A

Clinical Study ID

NCT03136341
GCO 17-0592
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with no presence of tremor during study functional tasks.
  • Presence of tremor during the functional task is below minimum amplitude required tobe 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 measuresthroughout the duration of the study.
  • Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure toother than the listed tremorogenic or potentially tremorogenic drugs is allowed onlyif, in the opinion of the investigator, this will not interfere with the study drugevaluations.

Study Design

Total Participants: 25
Study Start date:
December 04, 2018
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

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