NCT01251367

Dysport® Adult Lower Limb Spasticity Follow-on Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (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 lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Conditions

• Post-stroke Spasticity
• Spasticity Post-Traumatic Brain Injury

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	I.M. (intramuscular) injection on day 1 of each treatment cycle.

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-12-01
• Last updated: 2022-09-28
• Results posted: 2017-11-09

Locations

50 sites across 11 countries: United States, Australia, Belgium, Czechia, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia