Actively Recruiting
Long-Term Study of Recombinant Botulinum Toxin Type A YY001 Injections for Adults with Upper Limb Spasticity
Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2026-04-02
300
Participants Needed
16
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of multiple treatments using recombinant botulinum toxin type A YY001 injections for adults with upper limb spasticity caused by stroke. This phase III, open-label, multicenter study focuses on adults aged 18 to 75 who have unilateral hemiplegia and functional difficulties related to upper limb spasticity. Participants will receive multiple intramuscular injections of YY001 prepared by reconstituting the powder with saline. Each treatment dose ranges from 200 to 400 units. The study tracks the impact of repeated treatments over time, monitoring safety and treatment response. Throughout the study, participants will be regularly assessed for adverse events, muscle spasticity changes using the Modified Ashworth Scale, functional improvements via the Disability Assessment Scale, and antibody development up to 48 weeks. Evaluations occur at specified intervals after each treatment to understand the treatments ongoing effects and safety profile.
CONDITIONS
Brief Title
A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity
Research Team
J
Jieru Bai
X
Xiaoyun Sun
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