Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Completed

Phase 4 Results N/A

Trial Description

The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 1 injection at day 0. The study will last for 6 months in each patient.
    ARM 1: Kind: Experimental
    Label: 2
    Description: Placebo
  • Botulinum toxin type A (Dysport®) Drug
    Intervention Desc: 1 injection, 500 U at day 0. The study will last for 6 months in each patient.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Dysport

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 Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position week 4
Secondary Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale) weeks 4, 8, 12 & 24
Secondary Voluntary and passive joint range of motion goniometer assessment weeks 4, 8, 12 & 24
Secondary Pain Assessment using visual analogue scale for pain weeks 4, 8, 12 & 24

Sponsors