CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 116 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.

Search/NCT00257660
NCT00257660Phase 3Completed
CompareCT.gov

A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

Ipsen·interventional·Posted Nov 23, 2005·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Cervical Dystonia. Completed, enrolled 116 participants across 22 sites in 2 countries.

Detailed Summary

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesRussia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 23, 2005
Enrollment StartOct 10, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.6 years ago

Interventions

Botulinum toxin type Abiological

500 units

Placebodrug

500 units