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A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
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
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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2024-09-14
Completion Date
2026-09-30
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Recombinant Botulinum Toxin Type A for injection (YY001)
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
BOTOX®
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
Placebo
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.
Locations (24)
Anhui Provincial Hospital
Hefei, Anhui, China
The Second People's Hospital of Hefei
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
RenMin Hospital Of Wuhan University
Wuhan, Hubei, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, China
Qilu Hospital of Shandong University
Qingdao, Shandong, China
Zibo Municipal Hospital
Zibo, Shandong, China
Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality, China
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi provincial people's Hospital
Taiyuan, Shanxi, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China