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

David M. Simpson

Status and phase

Enrolling

Phase 4

Conditions

Tremor, Limb

Treatments

Drug: Abobotulinum toxin A

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03136341

GCO 17-0592

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.