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

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ClinicalTrials.gov Identifier: NCT03136341
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
David M. Simpson, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Tremor, Limb Drug: Abobotulinum toxin A Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants are randomized to receive either study drug or placebo at the initial phase and cross over 12 weeks later and receive the alternative treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Videos will be randomly provided to an outside assessor to determine benefit as a secondary outcome measure
Primary Purpose: Treatment
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
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Tremor

Arm Intervention/treatment
Active Comparator: Abobotulinum toxin A Drug: Abobotulinum toxin A
Dosing will be determined at each study visit based upon muscles involved

Placebo Comparator: Placebo Other: Placebo
Dosing will be determined at each study visit based upon muscles involved




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136341


Contacts
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Contact: Mary-Catherine George 212-241-0784 Mary-Catherine.George@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Mary-Catherine George    212-824-0784    mary-catherine.george@mssm.edu   
Contact: David M Simpson, MD    212-241-8748    david.simpson@mssm.edu   
Principal Investigator: David M Simpson, MD         
Sponsors and Collaborators
David M. Simpson
Ipsen
Investigators
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Principal Investigator: David M Simpson, MD Icahn School of Medicine at Mount Sinai

Publications:

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Responsible Party: David M. Simpson, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03136341     History of Changes
Other Study ID Numbers: GCO 17-0592
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David M. Simpson, Icahn School of Medicine at Mount Sinai:
Upper Limb
Tremor
task-dependent
Additional relevant MeSH terms:
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Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
abobotulinumtoxinA
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents