Dysport® Adult Lower Limb Spasticity Study

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 lower limb spasticity due to stroke or traumatic brain injury.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: I.M. injection on day 1 (single treatment cycle)
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: I.M., on day 1 (single treatment cycle)
  • Botulinum type A toxin (Dysport®) Drug
    Other Names: AbobotulinumtoxinA (non-proprietary name)
    Intervention Desc: I.M. injection on day 1 (single treatment cycle)
    ARM 1: Kind: Experimental
    Label: Dysport 1000 U, IM
    Description: 1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
    ARM 2: Kind: Experimental
    Label: Dysport 1500 U, IM
    Description: 1500 U, I.M., on day 1 (single treatment cycle)
    ARM 3: Kind: Experimental
    Label: Dysport® 1000 U, IM
    Description: 1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
    ARM 4: Kind: Experimental
    Label: Dysport® 1500 U, IM
    Description: 1500 U, I.M., on day 1 (single treatment cycle)

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 the Modified Ashworth scale Change from baseline at week 4 No
Secondary Physician's global assessment (PGA) of the treatment response Week 4 No
Secondary Walking speed Change from baseline at week 4 No
Primary Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended) Baseline and Week 4
Secondary Physician's Global Assesment (PGA) of Treatment Response at Week 4 At Week 4
Secondary Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed Baseline and Week 4

Sponsors