Spasticity Clinical Trial
Official title:
A Randomized, Double Blind, Multi-center, Active Drug Controlled Clinical Trial to Compare the Efficacy and Safety of MEDITOXIN® Versus BOTOX® in Treatment of Post Stroke Upper Limb Spasticity
This study is a randomized, double blind, multi-center, active drug controlled, phase III
clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of
post stroke upper limb(wrist, finger, thumb) spasticity
Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single
treatment of intramuscular Investigational product up to 360U. The subjects will be observed
every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale
(MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or
caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change
from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth
Scale. Safety parameters will also be measured including adverse events, vital signs and
clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Each completed subject will attend 4~5 clinic visits. The maximum study duration is 15 weeks. Only one upper limb (eligible inclusion/exclusion criteria) will be injected and evaluated in the study. Maximun injection dose is 360U. ;
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