A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of 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)
1 other identifier
interventional
300
1 country
16
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedStudy Start
First participant enrolled
March 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 2, 2026
March 1, 2026
1.2 years
March 11, 2026
March 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events and Serious Adverse Events
Up to 48 weeks
Secondary Outcomes (5)
Physician's Global Assessment (PGA) Score
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Change From Baseline in MAS Score of Primary Target Clinical Pattern
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point
Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies
Up to 48 weeks
Study Arms (1)
Recombinant botulinum toxin type A (YY001)
EXPERIMENTALMultiple injection with recombinant botulinum toxin type A for injection (YY001) in upper limb spasticity
Interventions
Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- History of allergy to any component of the experimental drugs.
- 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.
- Fixed contractures of the studied limb.
- Any medical condition that may increase the risk to the subject when using botulinum toxin type A.
- Need for treatment with drugs that interfere with neuromuscular function during the study.
- Plan or anticipate to use new antispasticity drugs during the study.
- History of epilepsy.
- Pregnant or breastfeeding women.
- Participation in other drug/device clinical trials within 1 month prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Peking Union Medical College Hospital
Beijing, China
West China Hospital，Sichuan University
Chengdu, China
Guangdong Provincial People's Hospital
Guangdong, China
Sun Yat-sen Memorial Hospital
Guangzhou, China
The Second People's Hospital of Hefei
Hefei, China
Huai'an First Hospital Affiliated to Nanjing Medical University
Huai'an, China
The First Affiliated Hospital of Henan University
Kaifeng, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
Shanghai Fudan University HuaShan Hospital
Shanghai, China
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, China
Shenzhen Second People's Hospital
Shenzhen, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Shanxi Bethune Hospital
Taiyuan, China
Tianjin Medical University General Hospital
Tianjin, China
Xuzhou Medical University Affiliated Hospital
Xuzhou, China
Zibo Municipal Hospital
Zibo, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2026
First Posted
March 18, 2026
Study Start
March 27, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share