A Phase II Study on Recombinant Botulinum Toxin Type a (YY001) for Injection in the Treatment of Upper Limb Spasticity in Adults

Launched by CHONGQING CLARUVIS PHARMACEUTICAL CO., LTD. · Jan 14, 2025

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ClinConnect Summary

This clinical trial is studying the effects of a new treatment called Recombinant Botulinum Toxin Type A (YY001) for adults who experience upper limb spasticity, a condition where certain muscles become stiff and difficult to control, often after a stroke. The goal is to see how well this treatment works and to ensure it is safe for patients. Participants in the trial must be between 18 and 75 years old, weigh at least 50 kg, and have experienced a stroke at least three months prior. They should also have specific difficulties with daily activities related to their upper limb.

If you decide to take part in this study, you will be randomly assigned to receive either the experimental treatment or a placebo (a substance with no therapeutic effect) to compare results. All participants will be monitored closely throughout the trial. It's important to note that those with certain medical conditions or who have used similar treatments recently may not be eligible. This trial is currently looking for participants, and it offers a chance to contribute to research that could help improve treatment options for people with spasticity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
• • 2. Weight ≥ 50 kg.
• • 3. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.
• • 4. 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).
• • 5. If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
• • 6. 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 Criteria:
• • 1. History of allergy to any component of the experimental drugs.
• • 2. 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.
• • 3. Fixed contractures of the studied limb.
• • 4. Any medical condition that may increase the risk to the subject when using Botulinum Toxin Type A.
• • 5. Need for treatment with drugs that interfere with neuromuscular function during the study.
• • 6. Plan or anticipate to use new antispasticity drugs during the study.
• • 7. History of epilepsy.
• • 8. Pregnant or breastfeeding women. Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.