A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity

Completed

Phase 3 Results N/A

Trial Description

Purpose: This study is a Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb(wrist, finger, elbow, thumb)Spasticity.

Conditions

Interventions

  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: Maximum dose 360 U
    ARM 1: Kind: Experimental
    Label: Botulinum toxin type A (DWP450)
    Description: DWP450: Botulinum toxin type A
    ARM 2: Kind: Experimental
    Label: Botulinum toxin type A (Botox®)
    Description: Botox®: Botulinum toxin type A

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The change in MAS(Modified Ashworth Scale)grade for Wrist flexor at 4 week No

Sponsors