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NCT Number: NCT03136341

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

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.

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Key information

Conditions

Tremor, Limb Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tremor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abobotulinum toxin A

Drug

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

Placebo

Other

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

Primary outcomes

  1. Patient's Impression of Change

    Time frame: Week 6

    The principal outcome measure will be patient's impression of change using visual analog scale. Visual Analog Scale (VAS) 100 point scale from 0 (no improvement) to 100 (normal use).

  2. Patient's Impression of Change

    Time frame: 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 outcomes

  1. Physician Global Impression of Change

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mary-Catherine George

CONTACT

[email protected]

212-241-0784

Sponsors and collaborators

Lead sponsor

David M. Simpson

Other

Collaborators

  • Ipsen

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 2, 2017
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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