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

Phase 4

Recruiting

• Conditions: Tremor, Limb
• Interventions: Drug: Abobotulinum toxin A; Other: Placebo

• Registration Number: NCT03136341
• Lead Sponsor: David M. Simpson

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-02
• Study Start: 2018-12-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Abobotulinum toxin A	Abobotulinum toxin A	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Patient's Impression of Change	Week 18	The principal outcome measure will be patient's impression of change using visual analog scale. Visual Analog Scale is a 100 point scale from 0 (no improvement) to 100 (normal use).

Secondary Outcome Measures

Name	Time	Method
Physician Global Impression of Change	Week 6	Physician global impression of change is measured by using a visual analog scale. The CGI using a VAS is rated on a 100-point scale, with the severity of illness scale using a range of responses from 0 (no improvement) through to 100 (normal use).illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States