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

RecruitingPhase 3Ages 18 Years - 80 YearsAllJHM BioPharma (Tonghua) Co. , Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Recombinant Botulinum Toxin Type A for injection
  • Placebo
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Where

31 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The Second People's Hospital of Hefei
Hefei, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Three Gorges Hospital affiliated to Chongqing University
Chongqing, China
Guangzhou Red Cross Hospital
Guangzhou, China
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Cangzhou Central Hospital
Cangzhou, China
The Second Hospital of Hebei Medical Hospital
Shijiazhuang, China

…and 23 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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