Recruiting

Abobotulinum Toxin A

Sponsor:

David M. Simpson

Code:

NCT03136341

Conditions

Tremor, Limb

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Abobotulinum toxin A

Placebo

Study Details

Brief 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

Study ID

NCT03136341

Start date

Dec 4, 2018

Status verified date

Feb, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Abobotulinum toxin A

placebo comparator: Placebo

Interventions

Abobotulinum toxin A

Dosing will be determined at each study visit based upon muscles involved

Placebo

Dosing will be determined at each study visit based upon muscles involved

Primary outcome measure

  • Patient's Impression of Change [ Time Frame: Week 6 ]
  • Patient's Impression of Change [ Time Frame: Week 18 ]

Central Contacts and Locations

Central contacts

Mary-Catherine George

212-241-0784Mary-Catherine.George@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Mary-Catherine George

212-824-0784mary-catherine.george@mssm.edu

David M Simpson, MD

212-241-8748david.simpson@mssm.edu

Principal Investigator:

David M Simpson, MD

More Information

Sponsor

David M. Simpson

Last update posted

Feb 25, 2021

Last verified

Feb, 2021

Keywords

  • Upper Limb
  • Tremor
  • task-dependent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David M. Simpson on 2021-02-25.