A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity
An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)
Chongqing Claruvis Pharmaceutical Co., Ltd.
300 participants
Mar 27, 2026
INTERVENTIONAL
Conditions
Summary
This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity
Eligibility
Inclusion Criteria3
- Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
- Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to enrollment) exhibiting upper limb spasticity.
- Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).
Exclusion Criteria9
- History of allergy to any component of the experimental drugs.
- Previous use of any botulinum toxin within 6 months prior to enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
- Fixed contractures of the studied limb.
- Any medical condition that may increase the risk to the subject when using botulinum toxin type A.
- Need for treatment with drugs that interfere with neuromuscular function during the study.
- Plan or anticipate to use new antispasticity drugs during the study.
- History of epilepsy.
- Pregnant or breastfeeding women.
- Participation in other drug/device clinical trials within 1 month prior to enrollment.
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Interventions
Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U.
Locations(16)
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NCT07478822