Dysport® Adult Upper Limb Spasticity

Completed

Phase 3 Results

Trial Description

The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: I.M. (in the muscle) injection on day 1 of a single treatment cycle.
    ARM 1: Kind: Experimental
    Label: Placebo
  • Botulinum type A toxin (Dysport®) Drug
    Other Names: AbobotulinumtoxinA (non-proprietary name)
    Intervention Desc: 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
    ARM 1: Kind: Experimental
    Label: Dysport 500 U
    ARM 2: Kind: Experimental
    Label: Dysport 1000 U

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Intensity of muscle tone rated by Modified Ashworth Scale Week 4 No
Secondary Physician's Global Assessment of treatment response Week 4 No
Secondary Upper limb passive function, using the Disability Assessment Scale Baseline and week 4 No
Primary Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) From Baseline (Day 1) to Week 4 No
Secondary Physician's Global Assessment (PGA) of Treatment Response At Week 4 No
Secondary Change From Baseline in DAS Score for the Principal Target of Treatment (PTT) From Baseline (Day 1) to Week 4 No

Sponsors