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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: JHM BioPharma (Tonghua) Co. , Ltd. • ClinicalTrials.gov ID: NCT07242300

Registry updated: 2026-09-23
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Description

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.

Interventions

  • Recombinant Botulinum Toxin Type A for injection (Drug)
    Recombinant Botulinum Toxin Type A for injection
  • Placebo (Drug)
    Placebo will be administered in double-blind fashion during treatment cycle 1 only

Eligibility criteria

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

Conditions

Upper Limb Spasticity (ULS)

Locations

  • The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China
  • The Second People's Hospital of Hefei — Hefei, Anhui, China
  • Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China
  • Three Gorges Hospital affiliated to Chongqing University — Chongqing, Chongqing Municipality, China
  • Guangzhou Red Cross Hospital — Guangzhou, Guangdong, China
  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China
  • Cangzhou Central Hospital — Cangzhou, Hebei, China
  • The Second Hospital of Hebei Medical Hospital — Shijiazhuang, Hebei, China
  • Oilfields General Hospital in Daqing — Daqing, Heilongjiang, China
  • The Second Hospital of Harbin — Harbin, Heilongjiang, China
  • The First Affiliated Hospital of Henan University — Kaifeng, Henan, China
  • Luoyang Central Hospital — Luoyang, Henan, China
  • The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
  • Zhengzhou People's Hospital — Zhengzhou, Henan, China
  • The Central Hospital of Wuhan — Wuhan, Hubei, China
  • Xiangyang First People's Hospital — Xiangyang, Hubei, China
  • The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
  • Huai 'an Second People's Hospital — Huai'an, Jiangsu, China
  • The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
  • Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
  • Pingxiang People's Hospital — Pingxiang, Jiangxi, China
  • Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China
  • Baotou Steel Hospital in Inner Mongolia — Baotou, Neimenggu, China
  • Yantai Mountain Hospital — Yantai, Shandong, China
  • Zibo municipal hospital — Zibo, Shandong, China
  • Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China
  • Yangzhi Affiliated Rehabilitation Hospital of Tongji University — Shanghai, Shanghai Municipality, China
  • Shanxi Bethune Hospital — Taiyuan, Shanxi, China
  • Xianyang Hospital of Yan 'an University — Xianyang, Shanxi, China
  • Meishan Cardiovascular and Cerebrovascular Hospital — Meishan, Sichuan, China
  • Taihe hospital of Shiyan City — Shiyan, Sichuan, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record