At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 134 enrolled
Drug / intervention
Botulinum toxin type A +1 morebiological
Likely dose
Botulinum toxin type A 500 unitsfrom 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 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Cervical Dystonia. Completed, enrolled 134 participants across 42 sites.
Detailed Summary
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartJan 2013
Primary CompletionOct 2014
Study CompletionJan 2015
TodayJul 2026
First PostedDec 20, 2012
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.5 years ago
Interventions
Botulinum toxin type Abiological
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Placebodrug
Up to 2mL