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NCT Number: NCT07242300

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

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Key information

Conditions

Upper Limb Spasticity (ULS)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant Botulinum Toxin Type A for injection

Drug

Recombinant Botulinum Toxin Type A for injection

Placebo

Drug

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

Primary outcomes

  1. Primary Outcome Measure

    Time frame: Within 4 weeks

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

Secondary outcomes

  1. Secondary Outcome Measure

    Time frame: Within 52 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Danhua Lin

CONTACT

[email protected]

15811460241

Lei Wang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

JHM BioPharma (Tonghua) Co. , Ltd.

Network

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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