CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 516 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.

Search/NCT00447772
NCT00447772Phase 3Completed
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Multicentre Open Study on the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia

Ipsen·interventional·Posted Mar 15, 2007·Updated Mar 30, 2023

In Brief

A Phase 3 clinical trial evaluating Botulinum toxin type A for Cervical Dystonia. Completed, enrolled 516 participants across 106 sites in 2 countries.

Detailed Summary

The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesAustria, Germany
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 15, 2007
Enrollment StartOct 1, 2004
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.3 years ago

Interventions

Botulinum toxin type Abiological

Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia