Actively Recruiting
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)
Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2026-04-02
300
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of multiple treatments using recombinant botulinum toxin type A (YY001) injections for adults with upper limb spasticity caused by stroke. This phase III, open-label, multicenter study focuses on adults aged 18 to 75 who have unilateral hemiplegia and functional difficulties related to upper limb spasticity. Participants will receive multiple intramuscular injections of YY001 prepared by reconstituting the powder with saline. Each treatment dose ranges from 200 to 400 units. The study tracks the impact of repeated treatments over time, monitoring safety and treatment response. Throughout the study, participants will be regularly assessed for adverse events, muscle spasticity changes using the Modified Ashworth Scale, functional improvements via the Disability Assessment Scale, and antibody development up to 48 weeks. Evaluations occur at specified intervals after each treatment to understand the treatment's ongoing effects and safety profile.
CONDITIONS
Brief Title
A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old inclusive at the time of consent
- Unilateral hemiplegia due to stroke with at least 3 months since stroke onset
- Upper limb spasticity with a Disability Assessment Scale score of at least 2 in one functional domain (hygiene, dressing, limb position, or pain)
You will not qualify if you...
- Allergy to any component of the study drug
- Use of any botulinum toxin within 6 months prior to enrollment or plans to use other botulinum toxins during the study
- Fixed contractures of the studied limb
- Medical conditions that increase risk with botulinum toxin type A
- Need for drugs interfering with neuromuscular function during the study
- Planned use of new antispasticity drugs during the study
- History of epilepsy
- Pregnant or breastfeeding women
- Participation in other drug or device clinical trials within 1 month prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive multiple injections of recombinant botulinum toxin type A (YY001) for upper limb spasticity.
Visits at Weeks 1, 4, 8, 12, 16, 20, and 24 after each treatment
Trial Site Locations
Total: 16 locations
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
2
West China Hospital，Sichuan University
Chengdu, China
Actively Recruiting
3
Guangdong Provincial People's Hospital
Guangdong, China
Actively Recruiting
4
Sun Yat-sen Memorial Hospital
Guangzhou, China
Actively Recruiting
5
The Second People's Hospital of Hefei
Hefei, China
Actively Recruiting
6
Huai'an First Hospital Affiliated to Nanjing Medical University
Huai'an, China
Actively Recruiting
7
The First Affiliated Hospital of Henan University
Kaifeng, China
Actively Recruiting
8
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
Actively Recruiting
9
Shanghai Fudan University HuaShan Hospital
Shanghai, China
Actively Recruiting
10
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, China
Actively Recruiting
11
Shenzhen Second People's Hospital
Shenzhen, China
Actively Recruiting
12
The First Affiliated Hospital of Soochow University
Suzhou, China
Actively Recruiting
13
Shanxi Bethune Hospital
Taiyuan, China
Actively Recruiting
14
Tianjin Medical University General Hospital
Tianjin, China
Actively Recruiting
15
Xuzhou Medical University Affiliated Hospital
Xuzhou, China
Actively Recruiting
16
Zibo Municipal Hospital
Zibo, China
Actively Recruiting
Research Team
J
Jieru Bai
X
Xiaoyun Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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