What is Recombinant Botulinum Toxin Type A (YY001) studying for upper limb spasticity?

Recombinant Botulinum Toxin Type A (YY001) is being studied to evaluate its safety and effectiveness in treating upper limb spasticity in adults after stroke. The trial compares YY001 with BOTOX4 and a placebo to find better treatment options. This research is sponsored by Chongqing Claruvis Pharmaceutical Co., Ltd.

Who may be eligible for this upper limb spasticity clinical trial?

Adults aged 18 to 75 years with upper limb spasticity caused by a stroke at least 3 months ago may be eligible. Both men and women can participate if they have a certain level of disability and stable antispasticity treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this upper limb spasticity clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and might not be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years - 75Years

All Genders

ID06783114

Study of Recombinant Botulinum Toxin Type A YY001 Injection to Treat Upper Limb Spasticity in Adults Aged 18 to 75

Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2026-01-22

254

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Recombinant Botulinum Toxin Type A YY001 injections for treating upper limb spasticity in adults who have had a stroke. This randomized, double-blind, multi-center phase IIIII study compares YY001 with BOTOX4 and a placebo to better understand treatment options for this condition. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A YY001 with a dose of 200-400 units, BOTOX4 with a dose of 200 units, or a placebo prepared with saline. The study includes three groups the experimental group receiving YY001, an active-controlled group receiving BOTOX4, and a placebo-controlled group. Each participant receives only one injection during the treatment period. During the study, participants will be monitored at 1, 4, 8, and 12 weeks after treatment through assessments such as the Modified Ashworth Scale MAS for spasticity, Physicians Global Assessment, and Disability Assessment Scale DAS. Researchers will also track any adverse events and the presence of antibodies to the treatment. The primary outcome is the change in MAS score at week 4. The study lasts at least 12 weeks with ongoing safety and efficacy follow-up.

CONDITIONS

Brief Title

A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 18 and 75 years old inclusive
Unilateral hemiplegia due to stroke with at least 3 months since stroke onset
Upper limb spasticity present
Disability Assessment Scale score of at least 2 on the principal treatment target
Stable oral antispasticity dosage for at least 1 month before enrollment if applicable
Stable physical or occupational therapy frequency, type, and intensity for at least 3 weeks before enrollment if applicable

You will not qualify if you...

Allergy to any component of the study drugs
Use of any botulinum toxin within 6 months before enrollment or planned use of other botulinum toxins during the study
Fixed contractures in the study limb
Medical conditions increasing risk from Botulinum Toxin Type A use
Need for drugs affecting neuromuscular function during the study
Planned use of new antispasticity drugs during the study
History of epilepsy
Pregnant or breastfeeding women
Participation in other drug or device clinical trials within 1 month before enrollment

Research Team

Jieru Bai

Xiaoyun Sun, Ph.D

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