This is a phase III clinical study to evaluate the efficacy and safety of recombinant botulinum toxin type A(Eveotox)in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of Eveotox compared with placebo in adult patients with upper limb spasticity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
Recombinant Botulinum Toxin Type A for injection
Placebo will be administered in double-blind fashion during treatment cycle 1 only
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Primary Outcome Measure
Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).
Time frame: Within 4 weeks
Secondary Outcome Measure
Incidence of adverse events and drug-related adverse events during the study.
Time frame: Within 52 weeks
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