Eveotox for Adult Upper Limb Spasticity: A Phase 3 Comparison to Placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, controlled study, adults with stable post-stroke upper limb spasticity will receive Eveotox injections or placebo to evaluate safety and how well it reduces spasticity and improves function. Eligible participants are 18–80 years old with MAS scores of 2 or higher at elbow, wrist, or finger flexors and a DAS score of at least 2 in one functional domain. The study excludes recent botulinum toxin use, certain infections or medical conditions, and active substance abuse. Primary sites include three hospitals in China, under lead sponsor JHM BioPharma (Tonghua).

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital of Bengbu Medical College
  Bengbu, Anhui, China Recruiting
• The Second People's Hospital of Hefei
  Hefei, Anhui, China Recruiting
• Three Gorges Hospital affiliated to Chongqing University
  Chongqing, Chongqing Municipality, China Recruiting
• Guangzhou Red Cross Hospital
  Guangzhou, Guangdong, China Recruiting
• Jiangbin Hospital of Guangxi Zhuang Autonomous Region
  Nanning, Guangxi, China Recruiting
• Cangzhou Central Hospital
  Cangzhou, Hebei, China Recruiting

Study contacts

• Study coordinator: Danhua Lin
• Email: danhua.lin@jhm-biopharma.com
• Phone: 15811460241

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Recombinant botulinum toxin (YY001) injections for adult upper limb spasticity.

  This trial will test repeated injections of recombinant botulinum toxin type A (YY001) to reduce muscle stiffness and improve function in adults with post-stroke upper limb spasticity.

  Recruiting at 16 sites Phase 3 Chongqing Claruvis Pharmaceutical Co., Ltd. · Beijing and 15 other locations · NCT07478822

• Using a new botulinum toxin injection to treat upper limb spasticity in adults

  This study is testing a new injection for adults with upper limb spasticity to see if it works better than current treatments like BOTOX® and helps improve their movement.

  Recruiting at 24 sites Phase 2/3 Chongqing Claruvis Pharmaceutical Co., Ltd. · Hefei, Anhui and 23 other locations · NCT06783114

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.