At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 112 enrolled
Drug / intervention
Botulinum toxin type Abiological
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 IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport® Using 2 mL Dilution In Adults With Cervical Dystonia
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A for Cervical Dystonia. Completed, enrolled 112 participants across 41 sites.
Detailed Summary
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartMar 2013
Primary CompletionOct 2015
TodayJul 2026
First PostedDec 20, 2012
Enrollment StartMar 1, 2013
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.5 years ago
Interventions
Botulinum toxin type Abiological
Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles