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

NCT07242300 | Not Yet Recruiting Phase 3

• 1 other identifier: JHM03-CT302
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Upper Limb Spasticity (ULS)

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

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

  Within 4 weeks

Secondary Outcomes (1)

• Secondary Outcome Measure

  Within 52 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

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

Placebo-Controlled Group

PLACEBO COMPARATOR

Placebo will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 cycles of Eveotox.

Drug: Placebo

Interventions

Recombinant Botulinum Toxin Type A for injection DRUG

Recombinant Botulinum Toxin Type A for injection

Treatment Group

Placebo DRUG

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

Placebo-Controlled Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JHM BioPharma (Tonghua) Co. , Ltd.: lead

Study Sites (2)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

Yangzhi Affiliated Rehabilitation Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Danhua Lin

CONTACT

15811460241; danhua.lin@jhm-biopharma.com

Lei Wang

CONTACT

lei.wang@jhm-biopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)