NCT01313312

Dysport® Adult Upper Limb Spasticity Extension Study

A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Detailed description

This was a phase III, multicentre, prospective, open label, repeat treatment cycles, extension to the double study Y-52-52120-145 (Study 145) . The study included both rollover subjects from Study 145 and de novo subjects. The primary study objective was to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles. The secondary study objective was to assess the long term efficacy of repeated treatment with Dysport®.

Conditions

• Nervous System Disorders

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	Dysport® was supplied to the study centres in vials containing 500 U of botulinum toxin type A (BTX-A). Depending on the dose administered up to 3 vials were required for the injection. Each vial was reconstituted with sodium chloride for injection (0.9%). A total volume of 5.0 mL of the reconstituted product was injected for Dysport® 500 U and 1000 U, and 7.5 mL was injected for Dysport® 1500 U.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-03-11
• Last updated: 2022-09-28
• Results posted: 2017-06-07

Locations

34 sites across 9 countries: United States, Belgium, Czechia, France, Hungary, Italy, Poland, Russia, Slovakia