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Kinematic-based BoNT-A Injections for Bilateral ET

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ClinicalTrials.gov Identifier: NCT02551848
Recruitment Status : Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mandar Jog, Western University, Canada

Brief Summary:
The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected utilizing kinematically-based injection parameters for the treatment of upper extremity essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment tools in determining injection parameters and to study the composition of tremor using kinematics.

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: Botulinum toxin type A Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A for Injection of Bilateral Upper Extremity Tremor in Patients With Essential Tremor Using Kinematic Assessment
Actual Study Start Date : August 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Tremor

Arm Intervention/treatment
Experimental: Essential tremor treatment

A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction.

Participants will be treated by BoNT-A injections every 12 weeks over 72 weeks. BoNT-A parameters will be determined solely by biomechanical analysis of tremulous movements in both upper extremity BoNT-A dose will range from 50-300 U per arm

Drug: Botulinum toxin type A
Other Names:
  • IncobotulinumtoxinA
  • BoNT-A
  • Xeomin




Primary Outcome Measures :
  1. Kinematic tremor severity [ Time Frame: 72 weeks ]
    Change from pre to post-BoNT-A treatments in maximum angular tremor amplitude at the wrist in each treated arm. Angular tremor amplitude is one parameter reflecting the vectoral intensity of tremor segmented at each arm joint


Secondary Outcome Measures :
  1. Clinical tremor severity [ Time Frame: 72 weeks ]
    Improvement in upper limb tremor severity as determined by an increase >8 points on a standardized clinical assessment tool (Fahn-Tolosa-Marin Tremor Assessment Scale) pre and post Xeomin® injection using kinematic-determined injection parameters in both ET upper limbs

  2. Accelerometric kinematic tremor severity [ Time Frame: 72 weeks ]
    Change from pre and post-BoNT-A treatments in maximum log-transformed accelerometric tremor amplitude at wrist level (injected limb). Log-transformed accelerometric tremor amplitude is one parameter reflecting the non-vectoral intensity of tremor.

  3. Quality of life measures [ Time Frame: 72 weeks ]
    Quality of life for essential tremor questionnaire is used to measure the patient's impression of change due to treatment and its change on their quality of life.



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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:

  • Consenting male and female participants
  • Diagnosis of 'definite essential tremor' in accordance with the TRIG criteria including: ET individuals diagnosed with upper limb tremor in their motor dominant and non-dominant hands
  • Stable ET medication management for the 3 month duration prior to their enrollment in the study
  • Participants who are botulinum toxin naïve for tremor management
  • Patients will be screened for pregnancy by the physician

Exclusion Criteria:

  • History of stroke
  • Muscle weakness or any related compartmental muscle syndrome
  • Smoking
  • History of ALS or Myasthenia Gravis
  • Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol)
  • Persons prescribed zonisamide
  • History of allergic or side effect reaction to botulinum toxin
  • Contraindications per the Xeomin® drug monograph
  • Women reporting that they are pregnant

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): NCT02551848


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Mandar Jog, MD LHSC

Publications:

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Responsible Party: Mandar Jog, Principal Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT02551848     History of Changes
Other Study ID Numbers: 104584
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Keywords provided by Mandar Jog, Western University, Canada:
Movement disorders
Botulinum toxin type A
Kinematics
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
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