drugset / Trial / NCT02668497

Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy

NCT02668497 ↗

Phase 2 Unknown 50 enrolled Western University, Canada
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective is to study the efficacy of botulinum toxin type A (BoNT-A) injected via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in Parkinson's disease (PD) tremor. Kinematic assessment tools already developed in past clinical studies will be used in determining injection parameters. The objective is to study the composition of PD tremor using kinematic tools which may contribute to the knowledge of tremor complexity and contribute information that would benefit the development of injection parameters to improve efficacy and optimization of BoNT-A in tremor management. By injecting all bothersome tremulous upper limbs in Parkinson's disease patients, the investigators believe a greater improvement in Quality of Life on more daily tasks can be achieved compared to the investigator's earlier study in unilateral injections (REB#101749), which already showed significant improvement.

Timeline

Start
2016-03
Primary completion
2020-08
Completion
2020-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 300 iu Intramuscular

Indications