A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
NCT ID: NCT06783114
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
254 participants
INTERVENTIONAL
2024-09-14
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group
Single injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity
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.
Active-Controlled Group
Single injection with BOTOX® in upper limb spasticity
BOTOX®
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
Placebo-Controlled Group
Single injection with placebo in upper limb spasticity
Placebo
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.
3. 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).
4. If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
5. 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.
Exclusion Criteria
2. 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.
3. Fixed contractures of the studied limb.
4. Any medical condition that may increase the risk to the subject when using Botulinum Toxin Type A.
5. Need for treatment with drugs that interfere with neuromuscular function during the study.
6. Plan or anticipate to use new antispasticity drugs during the study.
7. History of epilepsy.
8. Pregnant or breastfeeding women.
9. Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.
18 Years
75 Years
ALL
No
Sponsors
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Chongqing Claruvis Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xinhua Wan
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YY001-002-CN01
Identifier Type: -
Identifier Source: org_study_id
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