Recombinant botulinum toxin (YY001) injections for adult upper limb spasticity.

An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)

This trial will test repeated injections of recombinant botulinum toxin type A (YY001) to reduce muscle stiffness and improve function in adults with post-stroke upper limb spasticity.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 16 sites (Beijing and 15 other locations)
• Trial ID: NCT07478822 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 3 trial in China administers multiple treatment cycles of recombinant botulinum toxin type A (YY001) to adults with unilateral post-stroke upper limb spasticity to gather long-term safety and efficacy data. Eligible participants are 18–75 years old, at least 3 months from stroke onset, and have a Disability Assessment Scale score of at least 2 on the principal target domain. Key exclusions include fixed contractures, allergy to study drug components, prior botulinum toxin use within 6 months, or need for medications that interfere with neuromuscular function. Participants receive injections at participating hospitals with scheduled follow-up visits to monitor adverse events and changes in muscle tone and functional outcomes.

Who should consider this trial

Good fit: Adults aged 18–75 with unilateral hemiplegia from stroke (≥3 months since onset), presenting upper limb spasticity and a Disability Assessment Scale score ≥2 on the target domain who have not received botulinum toxin in the last 6 months are typical candidates.

Not a fit: Patients with fixed contractures, known allergy to the drug, recent botulinum toxin exposure, or who require neuromuscular-interfering medications are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, YY001 injections could reduce spastic muscle tone, improve arm function, and make daily care tasks easier for adults after stroke.

How similar studies have performed: Other botulinum toxin type A products have shown benefit for post-stroke upper limb spasticity, so the general approach is established even though YY001 is a novel recombinant formulation in late-stage testing.

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 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).

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 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 enrollment.

Where this trial is running

Beijing and 15 other locations

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

Study contacts

• Study coordinator: Jieru Bai

Conditions Upper Limb Spasticity; Botulinum Toxin; Recombinant Botulinum Toxin Type A; YY001; Upper limb spasticity