Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02668497 |
Date of registration:
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26/01/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy
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Scientific title:
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Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy |
Date of first enrolment:
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March 2016 |
Target sample size:
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50 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02668497 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Mandar Jog, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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LHSC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease
- PD participants who are naïve to PD medications will be grouped into the "De novo" PD
group
- PD participants stable on a low dose of Levodopa or on their PD medications for at
least 3 months prior to their study enrolment will be grouped into the "L-dopa" PD
group
- Participants who are botulinum toxin naïve for tremor management
- Patients will be screened for pregnancy by the physician
- Individuals with PD will be eligible for the study only if tremor is their primary and
most bothersome symptom as determined by clinical exam and patient report denoting
tremor-dominant phenotype
- Participants must be able to provide informed consent and to complete all study
assessment scales and tasks.
Exclusion Criteria:
- History of stroke
- History of ALS or Myasthenia Gravis
- History of COPD or emphysema
- Underlying arm muscle weakness or any related compartmental muscle syndrome
- 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 BoNT-A drug monograph
- Women reporting that they are pregnant
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Botulinum Toxin Type A
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Primary Outcome(s)
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Kinematic tremor severity
[Time Frame: 42 weeks]
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Secondary Outcome(s)
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Accelerometric kinematic tremor severity
[Time Frame: 42 weeks]
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Clinical tremor severity
[Time Frame: 42 weeks]
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Quality of life measures
[Time Frame: 42 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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