Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection in the Treatment of Adult Upper Limb Spasticity .
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Recombinant Botulinum Toxin Type A for injection, Placebo.
- Who it may be relevant to
- Registry conditions: Upper Limb Spasticity (ULS). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug Recombinant Botulinum Toxin Type A for injection
Recombinant Botulinum Toxin Type A for injection - Drug Placebo
Placebo will be administered in double-blind fashion during treatment cycle 1 only
Primary outcome measures
- Primary Outcome Measure [Time frame: Within 4 weeks]
Secondary outcome measures (1)
- Secondary Outcome Measure [Time frame: Within 52 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 12 centers
- Beijing Tsinghua Changgung Hospital — Beijing
- The Second Hospital of Hebei Medical Hospital — Shijiazhuang
- Luoyang Central Hospital — Luoyang
- The Second Affiliated Hospital of Zhengzhou University — Zhengzhou
- The Second Xiangya Hospital of Central South University — Changsha
- Huai 'an Second People's Hospital — Huai'an
- The Second Affiliated Hospital of Soochow University — Suzhou
- Pingxiang People's Hospital — Pingxiang
- … and 4 more centers
Identifiers
NCT: NCT07242300 · JHM03-CT302