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

JHM BioPharma (Tonghua) Co. , Ltd.

Status and phase: Not yet enrolling; Phase 3

Conditions: Upper Limb Spasticity (ULS)

Treatments: Drug: Placebo; Drug: Recombinant Botulinum Toxin Type A for injection

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07242300

JHM03-CT302

Details and patient eligibility

About

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.

Enrollment: 207 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

Treatment Group

Active Comparator group

Description:

Eveotox will be administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles of Eveotox.

Treatment:

Drug: Recombinant Botulinum Toxin Type A for injection

Placebo-Controlled Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo