A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults

January 20, 2026 updated by: Chongqing Claruvis Pharmaceutical Co., Ltd.

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

254

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Zhaozhao Cheng
        • Contact:
      • Hefei, Anhui, China
        • Recruiting
        • The Second People's Hospital of Hefei
        • Contact:
        • Principal Investigator:
          • Juncang Wu
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Xinhua Wan
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Principal Investigator:
          • Oumei Cheng
        • Contact:
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing Traditional Chinese Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Chenyu Li
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Principal Investigator:
          • jiehao zhao
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Shaoling Wu
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
        • Principal Investigator:
          • Jianjun Long
    • Henan
      • Kaifeng, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University
        • Contact:
        • Principal Investigator:
          • Qingyan Qin
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
        • Principal Investigator:
          • Hongjuan Dong
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Recruiting
        • Huai'an First People's Hospital
        • Contact:
        • Principal Investigator:
          • Yujun Qi
      • Suzhou, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
        • Principal Investigator:
          • Qi Fang
      • Suzhou, Jiangsu, China
        • Recruiting
        • The Fourth Affiliated Hospital of Soochow University
        • Contact:
        • Principal Investigator:
          • Qi Fang
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Xuzhou Medical University Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Jie Xiang
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Cuiping Zhao
      • Zibo, Shandong, China
        • Recruiting
        • Zibo Municipal Hospital
        • Contact:
        • Principal Investigator:
          • Runmin Sun
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Jun Liu
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Fudan University HuaShan Hospital
        • Principal Investigator:
          • Fang Li
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Yangzhi Affiliated Rehabilitation Hospital of Tongji University
        • Contact:
        • Principal Investigator:
          • Lingjing Jin
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
        • Principal Investigator:
          • Pingzhi Wang
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Principal Investigator:
          • Qin Wu
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital,Sichuan University
        • Principal Investigator:
          • Huifang Shang
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Xiaodong Zhu
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Liqing Yao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
  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:

  1. History of allergy to any component of the experimental drugs.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Single injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity
Biological: 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 Comparator: Active-Controlled Group
Single injection with BOTOX® in upper limb spasticity
Biological: BOTOX®
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
Placebo Comparator: Placebo-Controlled Group
Single injection with placebo in upper limb spasticity
Biological: Placebo
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4
Time Frame: Week 4 after treatment

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12
Time Frame: Week 1, Week 4, Week 8 and Week 12 after treatment
The Physician's Global Assessment is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point scale that ranges from -3 = very much worse to +3 = very much improved.
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
Time Frame: Week 1, Week 8 and Week 12 after treatment
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
Time Frame: Week 1, Week 4, Week 8 and Week 12 after treatment

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.

Subjects with a MAS reduction of one point were defined as responder.
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
Time Frame: Week 1, Week 4, Week 8 and Week 12 after treatment
The DAS consists of the four domains hygiene, dressing, limb position and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Week 1, Week 4, Week 8 and Week 12 after treatment
Incidence of Adverse Events and Serious Adverse Events
Time Frame: Within 12 weeks of treatment
Within 12 weeks of treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies
Time Frame: Within 12 weeks of treatment
Within 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Xinhua Wan, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YY001-002-CN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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