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Upper Limb Spasticity (ULS)Phase 3NCT07242300

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

A Phase 3 study testing Recombinant Botulinum Toxin Type A for injection in people with Upper Limb Spasticity (ULS), run by JHM BioPharma (Tonghua) Co. , Ltd. at 31 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Upper Limb Spasticity (ULS)
What is being tested?
Recombinant Botulinum Toxin Type A for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
31 sitesChina
Study dates
11 Dec 2025to Jan 2028
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Danhua Lin contact

15811460241

danhua.lin@jhm-biopharma.com

Lei Wang contact

lei.wang@jhm-biopharma.com

31 sites in 1 country

China31 sites, 30 recruiting

  • Baotou Steel Hospital in Inner Mongolia

    Baotou, Neimenggu

    Hongzhe Bi

    Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality

    Yu Pan, py10335@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

    Lei Xu

    Recruiting

  • Cangzhou Central Hospital

    Cangzhou, Hebei

    Yujuan Jiang

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Ying Kong, kongying1502@163.com

    Recruiting

  • Three Gorges Hospital affiliated to Chongqing University

    Chongqing, Chongqing Municipality

    Shengli Chen

    Recruiting

  • Oilfields General Hospital in Daqing

    Daqing, Heilongjiang

    Jianghua Liu

    Recruiting

  • Guangzhou Red Cross Hospital

    Guangzhou, Guangdong

    Zhiwei Mu

    Recruiting

  • The Second Hospital of Harbin

    Harbin, Heilongjiang

    Hongying Li

    Recruiting

  • The Second People's Hospital of Hefei

    Hefei, Anhui

    Juncang Wu

    Recruiting

  • Huai 'an Second People's Hospital

    Huai'an, Jiangsu

    Active, not recruiting

  • The First Affiliated Hospital of Henan University

    Kaifeng, Henan

    Qingyan Qin

    Recruiting

  • Luoyang Central Hospital

    Luoyang, Henan

    Ge Zhang, zhangge_cn@hotmail.com

    Recruiting

  • Meishan Cardiovascular and Cerebrovascular Hospital

    Meishan, Sichuan

    Rong Zhang

    Recruiting

  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

    Xibao Luo

    Recruiting

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi

    Jianzhong Xiong, 632710985@qq.com

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality

    Fang Li, fangl@fudan.edu.cn

    Recruiting

  • Yangzhi Affiliated Rehabilitation Hospital of Tongji University

    Shanghai, Shanghai Municipality

    Lingjing Jin, lingjingjin@163.com

    Recruiting

  • Shengjing Hospital affiliated to China Medical University

    Shenyang, Liaoning

    Lixin Zhang, 18940251875@163.com

    Recruiting

  • The Second Hospital of Hebei Medical Hospital

    Shijiazhuang, Hebei

    Yaling Liu, lyldoctor@163.com

    Recruiting

  • Taihe hospital of Shiyan City

    Shiyan, Sichuan

    Xiaohu Zhu

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Weifeng Luo, lwfwxx@126.com

    Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

    Pingzhi Wang

    Recruiting

  • The Central Hospital of Wuhan

    Wuhan, Hubei

    Chaoyang Ma

    Recruiting

  • Xiangyang First People's Hospital

    Xiangyang, Hubei

    Xudong Ding

    Recruiting

  • Xianyang Hospital of Yan 'an University

    Xianyang, Shanxi

    Aihong Guo

    Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Jie Xiang

    Recruiting

  • Yantai Mountain Hospital

    Yantai, Shandong

    Jianhua Tang, tangjianhua98@126.com

    Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Rui Wu, lvchengwutong@163.com

    Recruiting

  • Zhengzhou People's Hospital

    Zhengzhou, Henan

    Long Tian

    Recruiting

  • Zibo municipal hospital

    Zibo, Shandong

    Zengqiang Sun

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
Recombinant Botulinum Toxin Type A for injection, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Botulinum Toxin Type A for injectionDrug

    Recombinant Botulinum Toxin Type A for injection

  • PlaceboDrug

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

Study groups in NCT07242300
Study groupRoleWhat they receive
Treatment GroupActive comparatorEveotox will be administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles of Eveotox.
Receives: Drug: Recombinant Botulinum Toxin Type A for injection
Placebo-Controlled GroupPlacebo comparatorPlacebo will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 cycles of Eveotox.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measure

    Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).

    Measured: Within 4 weeks

Secondary outcomes (1)

  1. Secondary Outcome Measure

    Incidence of adverse events and drug-related adverse events during the study.

    Measured: Within 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start11 Dec 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
207 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07242300
Sponsor's protocol ID
JHM03-CT302
Status last verified
Sep 2026
First submitted
17 Nov 2025
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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