At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 382 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, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Cervical Dystonia. Completed, enrolled 382 participants across 57 sites in 11 countries.
Detailed Summary
The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesAustralia, Austria, Belgium, Czechia, France, Germany, Hungary, Poland, Portugal, Russia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartApr 2011
Primary CompletionMay 2012
Study CompletionJun 2013
TodayJul 2026
First PostedDec 16, 2010
Enrollment StartApr 1, 2011
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.5 years ago
Interventions
Botulinum toxin type Abiological
I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.
Botulinum toxin type Abiological
I.M. injection on day 1 of treatment cycle 1.
Placebodrug
I.M. injection on day 1 of treatment cycle 1.