A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults (REHAB-1)
Chongqing Claruvis Pharmaceutical Co., Ltd.
254 participants
Sep 14, 2024
INTERVENTIONAL
Conditions
Summary
This is a randomized, double-blind, multi-center phase II/III study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults
Eligibility
Inclusion Criteria5
- 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 randomized 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).
- If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
- If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.
Exclusion Criteria9
- History of allergy to any component of the experimental drugs.
- Previous use of any botulinum toxin within 6 months prior to randomized 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 randomized enrollment.
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Interventions
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.
Locations(24)
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NCT06783114