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

ClinicalTrials.gov ID

NCT06783114

Lead Sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.INDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2Phase 3

Enrollment

254Estimated

Last Update Posted

Jan 22, 2026Actual

Start Date

Sep 14, 2024Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

Official Title

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)

Brief 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

• Upper Limb Spasticity

• Recombinant Botulinum Toxin Type A for injection (YY001)
• BOTOX®
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.
3. 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).
4. If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
5. 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.
9. Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.INDUSTRY

wujuncang126@126.com

13660183777@126.com

longjianjun@szu.edu.cn

dhjdhjdhj027@sina.com

1964708102@qq.com

zhaocuipingzsu@126.com

runmingsun@126.com

wpzcxl@163.com

liyujun-wuqin@163.com

• A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

  NCT07478822

  RecruitingInterventionalPhase 3Updated Apr 2, 2026
• A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

  NCT05743634

  CompletedInterventionalPhase 1Phase 2Updated Feb 24, 2023
• A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

  NCT06583486

  CompletedInterventionalPhase 3Updated Jun 29, 2026
• Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection in the Treatment of Adult Upper Limb Spasticity .

  NCT07242300

  RecruitingInterventionalPhase 3Updated Aug 5, 2026
• Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

  NCT01392300

  CompletedInterventionalPhase 3Updated Jan 16, 2017
• A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity

  NCT01153815

  CompletedInterventionalPhase 3Updated Jun 28, 2017