Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection in the Treatment of Adult Upper Limb Spasticity .
NCT ID: NCT07242300
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
207 participants
INTERVENTIONAL
2026-01-31
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group
Eveotox will be administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles of Eveotox.
Recombinant Botulinum Toxin Type A for injection
Recombinant Botulinum Toxin Type A for injection
Placebo-Controlled Group
Placebo will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 cycles of Eveotox.
Placebo
Placebo will be administered in double-blind fashion during treatment cycle 1 only
Interventions
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Recombinant Botulinum Toxin Type A for injection
Recombinant Botulinum Toxin Type A for injection
Placebo
Placebo will be administered in double-blind fashion during treatment cycle 1 only
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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JHM BioPharma (Tonghua) Co. , Ltd.
NETWORK
Responsible Party
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Locations
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Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JHM03-CT302
Identifier Type: -
Identifier Source: org_study_id
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