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)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
West China Hospital，Sichuan University
RECRUITING
Chengdu
Guangdong Provincial People's Hospital
RECRUITING
Guangdong
Sun Yat-sen Memorial Hospital
RECRUITING
Guangzhou
The Second People's Hospital of Hefei
RECRUITING
Hefei
Huai'an First Hospital Affiliated to Nanjing Medical University
RECRUITING
Huai'an
The First Affiliated Hospital of Henan University
RECRUITING
Kaifeng
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Shanghai Fudan University HuaShan Hospital
RECRUITING
Shanghai
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
RECRUITING
Shanghai
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Xuzhou Medical University Affiliated Hospital
RECRUITING
Xuzhou
Zibo Municipal Hospital
RECRUITING
Zibo
Contact Information
Primary
Jieru Bai
bai.jieru@claruvis.com
+86 13883955310
Backup
Xiaoyun Sun
sun.xiaoyun@claruvis.com
Time Frame
Start Date: 2026-03-27
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 300
Treatments
Experimental: Recombinant botulinum toxin type A (YY001)
Multiple injection with recombinant botulinum toxin type A for injection (YY001) in upper limb spasticity
Related Therapeutic Areas
Sponsors
Leads: Chongqing Claruvis Pharmaceutical Co., Ltd.