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.
Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
Participants with stable post-stroke Spasticity (ULS) for at least 3 months
Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor
Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain)
Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
History of alcohol or drug abuse.
Known allergy or hypersensitivity to any component of the study products.
History of epilepsy
Parallel
Recombinant Botulinum Toxin Type A for injection
DrugRecombinant Botulinum Toxin Type A for injection
Placebo
DrugPlacebo will be administered in double-blind fashion during treatment cycle 1 only
Primary Outcome Measure
Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).
Secondary Outcome Measure
Incidence of adverse events and drug-related adverse events during the study.
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This trial is not recruiting at the moment. You can still explore other options:
