Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity

Completed

Phase 3 Results N/A

Trial Description

The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to Botox® reducing upper limb muscle tone in post stroke patients.

Conditions

Interventions

  • Botulinum toxin type A(Botulax®) Biological
    Intervention Desc: IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone
    ARM 1: Kind: Experimental
    Label: Botulinum toxin type A(Botulax®)
    Description: Botulinum toxin type A
  • Botulinum toxin type A(Botox®) Biological
    ARM 1: Kind: Experimental
    Label: Botulinum toxin type A(Botox®)
    Description: Botulinum toxin type A

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The change in MAS(Modified Ashworth Scale) grade from baseline at week 4 No
Secondary The change in muscle tone on MAS (Modified Ashworth Scale)for elbow, finger, and thumb flexor from baseline at week 4 No
Secondary The change in muscle tone on MAS (Modified Ashworth Scale)for wrist, elbow, finger, and thumb flexor from baseline at week 8 and 12 No
Secondary The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target from baseline at week 4, 8, 12 No
Secondary Global assessment evaluated by investigator at week 4, 8, 12 No
Secondary Global assessment evaluated by patients at week 4, 8, 12 No
Secondary The change in carer burden on Caregiver Burden Scale evaluated by caregiver from baseline at week 4, 8, 12 No

Sponsors