At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 103 enrolled
Drug / intervention
Dysport® (abobotulinumtoxinA) +1 moredrug
Likely dose
Dysport® (abobotulinumtoxinA) 500IUfrom 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 Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia
In Brief
A Phase 4 clinical trial evaluating Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) for Cervical Dystonia. Completed, enrolled 103 participants across 7 sites.
Detailed Summary
1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia. 2. double blind, randomised, multi center, crossover study
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesSouth Korea
CollaboratorsIpsen, Medical Research Collaborating Center, Seoul, Korea
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedAug 2009
Primary CompletionJan 2011
Study CompletionJul 2011
TodayJul 2026
First PostedAug 3, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.9 years ago
Interventions
Dysport® (abobotulinumtoxinA)drug
Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Botox® (onabotulinumtoxinA)drug
Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units