At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 352 enrolled
Drug / intervention
Botulinum toxin type Abiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A for Post-stroke Spasticity and Spasticity Post-Traumatic Brain Injury. Completed, enrolled 352 participants across 50 sites in 11 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Czechia, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartJun 2011
Primary CompletionApr 2015
TodayJul 2026
First PostedDec 1, 2010
Enrollment StartJun 1, 2011
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.6 years ago
Interventions
Botulinum toxin type Abiological
I.M. (intramuscular) injection on day 1 of each treatment cycle.