Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection in the Treatment of Adult Upper Limb Spasticity .
Recruiting
Phase 3
Interventional Study
Upper Limb Spasticity (ULS)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 207 (estimated)
- Sponsor
- JHM BioPharma (Tonghua) Co. , Ltd. · Research network
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Contacts