At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 243 enrolled
Drug / intervention
Botulinum toxin type A +2 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, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety 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
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Nervous System Disorders. Completed, enrolled 243 participants across 40 sites in 9 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 upper limb spasticity due to stroke or traumatic brain injury.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNervous System Disorders
CountriesBelgium, Czechia, France, Hungary, Italy, Poland, Russia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartAug 2011
Primary CompletionSep 2013
TodayJul 2026
First PostedMar 11, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.3 years ago
Interventions
Botulinum toxin type Abiological
500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Botulinum toxin type Abiological
1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebodrug
I.M. (in the muscle) injection on day 1 of a single treatment cycle.