Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02668497
• Date of registration: 26/01/2016
• Prospective Registration: Yes
• Primary sponsor: Western University, Canada
• Public title: Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy
• Scientific title: Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy
• Date of first enrolment: March 2016
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02668497
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Mandar Jog, MD
• Affiliation: LHSC

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Botulinum Toxin Type A

Primary Outcome(s)

Kinematic tremor severity [Time Frame: 42 weeks]

Secondary Outcome(s)

Accelerometric kinematic tremor severity [Time Frame: 42 weeks]

Clinical tremor severity [Time Frame: 42 weeks]

Quality of life measures [Time Frame: 42 weeks]

Secondary ID(s)

107433

Source(s) of Monetary Support

Please refer to primary and secondary sponsors