Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression "ONTIME Pilot"

Completed

Phase 4 Results N/A

Trial Description

The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance of the progression of upper limb symptomatic spasticity.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo administered intramuscularly in the targeted upper limb.
    ARM 1: Kind: Experimental
    Label: Placebo Group
    Description: Placebo intramuscular injection
  • AbobotulinumtoxinA Drug
    Other Names: Dysport®
    Intervention Desc: Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.
    ARM 1: Kind: Experimental
    Label: Treatment group
    Description: Dysport® 500U intramuscular injection
  • BotulinumtoxinA Drug
    Other Names: Dysport®
    Intervention Desc: Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.
    ARM 1: Kind: Experimental
    Label: Treatment group
    Description: Dysport® 500U intramuscular injection

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Time between the initial injection and reinjection criteria occurrence Week 4 and up to 28 weeks No
Secondary Change in muscle tone using Modified Ashworth Scale (MAS) Week 4 and every 4 weeks up to 28 weeks No
Secondary Median time from initial injection to re-injection visit Week 4 and every 4 weeks up to 28 weeks No
Secondary Mean change in Fugl-Meyer Assessment (FMA) from initial injection visit to re-injection visit Week 4 and every 4 weeks up to 28 weeks No
Secondary Change in Global assessment of changes assessed by the investigator Week 4 and up to 28 weeks No

Sponsors