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

November 17, 2025 updated by: JHM BioPharma (Tonghua) Co. , Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Yangzhi Affiliated Rehabilitation Hospital of Tongji University
        • Contact:
      • Shanghai, Shanghai Municipality, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment Group
Eveotox will be administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles of Eveotox.
Drug: Recombinant Botulinum Toxin Type A for injection
Recombinant Botulinum Toxin Type A for injection
Placebo Comparator: Placebo-Controlled Group
Placebo will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 cycles of Eveotox.
Drug: Placebo
Placebo will be administered in double-blind fashion during treatment cycle 1 only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measure
Time Frame: Within 52 weeks
Incidence of adverse events and drug-related adverse events during the study.
Within 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JHM BioPharma (Tonghua) Co. , Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHM03-CT302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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