Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07478822

A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2026-04-02

300

Participants Needed

16

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old inclusive at the time of informed consent
  • Unilateral hemiplegia caused by stroke with at least 3 months since stroke onset
  • Disability Assessment Scale score of 2 or more on the Principal Target of Treatment in hygiene, dressing, limb position, or pain
Not Eligible

You will not qualify if you...

  • Allergy to any component of the study drug
  • Use of any botulinum toxin within 6 months before enrollment or planned use of other botulinum toxins not in the study during the trial
  • Fixed contractures in the limb being studied
  • Any medical condition increasing risk with botulinum toxin type A use
  • Need for drugs that affect neuromuscular function during the study
  • Planned or anticipated 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

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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

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Research Team

J

Jieru Bai

CONTACT

X

Xiaoyun Sun

CONTACT

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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