A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
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)
1 other identifier
interventional
254
1 country
24
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2024
24 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
Study Start
First participant enrolled
September 14, 2024
CompletedFirst Submitted
Initial submission to the registry
January 14, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
January 22, 2026
January 1, 2026
2 years
January 14, 2025
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist. The Modified Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 6-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Week 4 after treatment
Secondary Outcomes (6)
Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12
Week 1, Week 4, Week 8 and Week 12 after treatment
Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12
Week 1, Week 8 and Week 12 after treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12
Week 1, Week 4, Week 8 and Week 12 after treatment
Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12
Week 1, Week 4, Week 8 and Week 12 after treatment
Incidence of Adverse Events and Serious Adverse Events
Within 12 weeks of treatment
- +1 more secondary outcomes
Study Arms (3)
Treatment Group
EXPERIMENTALSingle injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity
Active-Controlled Group
ACTIVE COMPARATORSingle injection with BOTOX® in upper limb spasticity
Placebo-Controlled Group
PLACEBO COMPARATORSingle injection with placebo in upper limb spasticity
Interventions
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.
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 randomized 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).
- If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
- If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.
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 randomized 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 randomized enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinhua Wan
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2025
First Posted
January 20, 2025
Study Start
September 14, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share