At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 388 enrolled
Drug / intervention
Botulinum toxin type A +1 morebiological
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, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Leg Spasticity. Completed, enrolled 388 participants across 62 sites in 11 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeg Spasticity
CountriesAustralia, Belgium, Czechia, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartMar 2011
Primary CompletionDec 2013
Study CompletionMay 2014
TodayJul 2026
First PostedNov 29, 2010
Enrollment StartMar 1, 2011
Primary CompletionDec 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.6 years ago
Interventions
Botulinum toxin type Abiological
I.M. injection on day 1 (single treatment cycle)
Placebodrug
I.M. injection on day 1 (single treatment cycle)