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Clinical Trials in China / NCT07242300
Recruiting Phase 3

Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection in the Treatment of Adult Upper Limb Spasticity .

NCT07242300 · tracked via the Priya Life Science China tracker
Sponsor
JHM BioPharma (Tonghua) Co. , Ltd.
Phase
Phase 3
Started
2025-12-11
Last updated
2026-09-23

Condition(s) studied

Upper Limb Spasticity (ULS)

Investigational drug(s) / intervention(s)

Recombinant Botulinum Toxin Type A for injectionPlacebo

Recombinant Botulinum Toxin Type A for injection: Recombinant Botulinum Toxin Type A for injection

Placebo: Placebo will be administered in double-blind fashion during treatment cycle 1 only

Study summary

This is a phase III clinical study to evaluate the efficacy and safety of recombinant botulinum toxin type A(Eveotox)in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of Eveotox compared with placebo in adult patients with upper limb spasticity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent * Participants with stable post-stroke Spasticity (ULS) for at least 3 months * Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor * Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain) * Participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity Exclusion Criteria: * Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study. * History of alcohol or drug abuse. * Known allergy or hypersensitivity to any component of the study products. * History of epilepsy * Known or suspected to be HIV positive, serologically positive for syphilis, or active hepatitis B or C * Any medical condition that may put the participant at increased risk for botulinum toxin type A use

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui Recruiting
The Second People's Hospital of Hefei Hefei Anhui Recruiting
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality Not Yet Recruiting
Three Gorges Hospital affiliated to Chongqing University Chongqing Chongqing Municipality Recruiting
Guangzhou Red Cross Hospital Guangzhou Guangdong Recruiting
Jiangbin Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi Recruiting
Cangzhou Central Hospital Cangzhou Hebei Recruiting
The Second Hospital of Hebei Medical Hospital Shijiazhuang Hebei Recruiting
Oilfields General Hospital in Daqing Daqing Heilongjiang Recruiting
The Second Hospital of Harbin Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Henan University Kaifeng Henan Recruiting
Luoyang Central Hospital Luoyang Henan Recruiting
The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Zhengzhou People's Hospital Zhengzhou Henan Recruiting
The Central Hospital of Wuhan Wuhan Hubei Recruiting
Xiangyang First People's Hospital Xiangyang Hubei Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Recruiting
Huai 'an Second People's Hospital Huai'an Jiangsu Active Not Recruiting
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Recruiting
Pingxiang People's Hospital Pingxiang Jiangxi Recruiting
Shengjing Hospital affiliated to China Medical University Shenyang Liaoning Recruiting
Baotou Steel Hospital in Inner Mongolia Baotou Neimenggu Recruiting
Yantai Mountain Hospital Yantai Shandong Recruiting
Zibo municipal hospital Zibo Shandong Recruiting
Huashan Hospital Fudan University Shanghai Shanghai Municipality Recruiting
Yangzhi Affiliated Rehabilitation Hospital of Tongji University Shanghai Shanghai Municipality Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Recruiting
Xianyang Hospital of Yan 'an University Xianyang Shanxi Recruiting
Meishan Cardiovascular and Cerebrovascular Hospital Meishan Sichuan Recruiting
Taihe hospital of Shiyan City Shiyan Sichuan Recruiting

More JHM BioPharma (Tonghua) Co. , Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07242300 on ClinicalTrials.gov ↗ ← All trials in China