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

Recruiting now · Phase 3

Conditions studied: Upper Limb Spasticity

In brief

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

Key facts

Study ID

NCT07478822

Run by

Chongqing Claruvis Pharmaceutical Co., Ltd.

People needed

300

Starts

2026-03-27

Expected to finish

2027-06-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Peking Union Medical College Hospital — Beijing, China (enrolling)
• West China Hospital，Sichuan University — Chengdu, China (enrolling)
• Guangdong Provincial People's Hospital — Guangdong, China (enrolling)
• Sun Yat-sen Memorial Hospital — Guangzhou, China (enrolling)
• The Second People's Hospital of Hefei — Hefei, China (enrolling)
• Huai'an First Hospital Affiliated to Nanjing Medical University — Huai'an, China (enrolling)
• The First Affiliated Hospital of Henan University — Kaifeng, China (enrolling)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, China (enrolling)
• Shanghai Fudan University HuaShan Hospital — Shanghai, China (enrolling)
• Yangzhi Affiliated Rehabilitation Hospital of Tongji University — Shanghai, China (enrolling)
• Shenzhen Second People's Hospital — Shenzhen, China (enrolling)
• The First Affiliated Hospital of Soochow University — Suzhou, China (enrolling)
• Shanxi Bethune Hospital — Taiyuan, China (enrolling)
• Tianjin Medical University General Hospital — Tianjin, China (enrolling)
• Xuzhou Medical University Affiliated Hospital — Xuzhou, China (enrolling)
• Zibo Municipal Hospital — Zibo, China (enrolling)

Full record on ClinicalTrials.gov

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