Actively Recruiting
A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2026-01-22
254
Participants Needed
24
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive at consent
- Unilateral hemiplegia due to stroke with at least 3 months since onset
- Upper limb spasticity present
- Disability Assessment Scale score of 2 or higher on the main treatment target (hygiene, dressing, limb position or pain)
- Stable dosage of oral antispasticity medication for at least 1 month prior to enrollment
- Stable physical or occupational therapy frequency, type, and intensity for at least 3 weeks prior to enrollment
You will not qualify if you...
- Allergy to any component of the study drugs
- Use of botulinum toxin within 6 months before enrollment or planned use of other botulinum toxins during the study
- Fixed contractures in the study limb
- Medical conditions increasing risk with Botulinum Toxin Type A use
- Need for drugs that affect neuromuscular function during the study
- Planned use of new antispasticity drugs during the study
- History of epilepsy
- Pregnancy or breastfeeding
- Participation in other drug or device clinical trials within 1 month before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
2
The Second People's Hospital of Hefei
Hefei, Anhui, China
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3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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4
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
6
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
7
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
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8
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
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9
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
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10
RenMin Hospital Of Wuhan University
Wuhan, Hubei, China
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11
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Actively Recruiting
12
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
13
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
14
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
15
Qilu Hospital of Shandong University
Qingdao, Shandong, China
Actively Recruiting
16
Zibo Municipal Hospital
Zibo, Shandong, China
Actively Recruiting
17
Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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18
Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
19
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Actively Recruiting
20
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
21
Shanxi provincial people's Hospital
Taiyuan, Shanxi, China
Actively Recruiting
22
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
23
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
24
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
Research Team
J
Jieru Bai
CONTACT
X
Xiaoyun Sun, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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