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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJHM BioPharma (Tonghua) Co. , Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Recombinant Botulinum Toxin Type A for injection
  • Placebo

Treatment groups

207 Participants
are divided into 2 treatment groups