Kinematic-guided BoNT-A Treatment for ET and PD Tremor

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study attempts to fill a critical knowledge gap of BoNT A in tremor management by studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in essential tremor and idiopathic Parkinson disease using data regarding composition of tremor obtained through sophisticated, yet clinically accessible multi-sensor based kinematic information.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western University, Canada
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Consenting male and female participants, aged 18 years to 80 years

• PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease or ET with hand tremor in their motor dominant hand

• Stable IPD/ET medication management for the 6 month duration prior to their enrollment in the study

• Individuals with IPD will be eligible for the study only if tremor is their primary and most bothersome symptom as determined by clinical exam and patient report

• Participants who are botulinum toxin naïve for tremor management

Exclusion Criteria:

• History of stroke

• Muscle weakness or any related compartmental muscle syndrome

• Smoking

• Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol))

• Contradictions per the Xeomin® drug monograph

• Patients prescribed zonisamide