RECRUITING

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

Conditions

Tremor, Limb Upper Limb Tremor task-dependent

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2018-12-04

Study Completion:2022-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03136341

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mary-Catherine George

CONTACT

212-241-0784

Mary-Catherine.George@mssm.edu

Principal Investigator

David M Simpson, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: David M. Simpson

David M Simpson, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-04

Study Completion Date2022-12

Study Record Updates

Study Start Date2018-12-04

Study Completion Date2022-12

Terms related to this study

Keywords Provided by Researchers

Upper Limb
Tremor
task-dependent

Additional Relevant MeSH Terms

Tremor, Limb