Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT06783114

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

Led by Chongqing Claruvis Pharmaceutical Co., Ltd. · Updated on 2026-01-22

254

Participants Needed

24

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years inclusive at consent
  • Unilateral hemiplegia due to stroke with at least 3 months since onset
  • Upper limb spasticity present
  • Disability Assessment Scale score of 2 or higher on the main treatment target (hygiene, dressing, limb position or pain)
  • Stable dosage of oral antispasticity medication for at least 1 month prior to enrollment
  • Stable physical or occupational therapy frequency, type, and intensity for at least 3 weeks prior to enrollment
Not Eligible

You will not qualify if you...

  • Allergy to any component of the study drugs
  • Use of botulinum toxin within 6 months before enrollment or planned use of other botulinum toxins during the study
  • Fixed contractures in the study limb
  • Medical conditions increasing risk with Botulinum Toxin Type A use
  • Need for drugs that affect neuromuscular function during the study
  • Planned use of new antispasticity drugs during the study
  • History of epilepsy
  • Pregnancy or breastfeeding
  • Participation in other drug or device clinical trials within 1 month before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

Anhui Provincial Hospital

Hefei, Anhui, China

Actively Recruiting

2

The Second People's Hospital of Hefei

Hefei, Anhui, China

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3

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

4

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China

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5

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

6

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Actively Recruiting

7

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

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8

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Actively Recruiting

9

The First Affiliated Hospital of Henan University

Kaifeng, Henan, China

Actively Recruiting

10

RenMin Hospital Of Wuhan University

Wuhan, Hubei, China

Actively Recruiting

11

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Actively Recruiting

12

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Actively Recruiting

13

The Fourth Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Actively Recruiting

14

Xuzhou Medical University Affiliated Hospital

Xuzhou, Jiangsu, China

Actively Recruiting

15

Qilu Hospital of Shandong University

Qingdao, Shandong, China

Actively Recruiting

16

Zibo Municipal Hospital

Zibo, Shandong, China

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17

Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Actively Recruiting

18

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

19

Yangzhi Affiliated Rehabilitation Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Actively Recruiting

20

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Actively Recruiting

21

Shanxi provincial people's Hospital

Taiyuan, Shanxi, China

Actively Recruiting

22

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Actively Recruiting

23

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

24

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Actively Recruiting

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Research Team

J

Jieru Bai

CONTACT

X

Xiaoyun Sun, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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