CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 233 enrolled
Drug / intervention
incobotulinumtoxinA (Xeomin) (240 Units) +2 moredrug
Likely dose
incobotulinumtoxinA (Xeomin) (240 Units)from 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/NCT00407030
NCT00407030Phase 3Completed
CompareCT.gov

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With a Double-blind Parallel-group Extension Period to Investigate the Efficacy and Safety of Different Doses of IncobotulinumtoxinA (Xeomin) in the Treatment of Cervical Dystonia

Merz Pharmaceuticals GmbH·interventional·Posted Dec 4, 2006·Updated Jul 19, 2013

In Brief

A Phase 3 clinical trial evaluating incobotulinumtoxinA (Xeomin) (240 Units), incobotulinumtoxinA (Xeomin) (120 Units), and 1 other intervention for Cervical Dystonia. Completed, enrolled 233 participants across 1 site.

Detailed Summary

At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2006
Enrollment StartJul 1, 2006
Primary CompletionJan 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.6 years ago

Interventions

incobotulinumtoxinA (Xeomin) (240 Units)drug

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units)

incobotulinumtoxinA (Xeomin) (120 Units)drug

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units)

Placebodrug

Placebo