CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 258 enrolled
Drug / intervention
Botulinum toxin type Abiological
Likely dose
Botulinum toxin type A 5.0 mLfrom 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.

Search/NCT01313312
NCT01313312Phase 3Completed
CompareCT.gov

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

Ipsen·interventional·Posted Mar 11, 2011·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating Botulinum toxin type A for Nervous System Disorders. Completed, enrolled 258 participants across 34 sites in 9 countries.

Detailed 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.

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 11, 2011
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.3 years ago

Interventions

Botulinum toxin type Abiological

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.