NCT00407030

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
DRUG	incobotulinumtoxinA (Xeomin) (240 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units)
DRUG	incobotulinumtoxinA (Xeomin) (120 Units)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units)
DRUG	Placebo	Placebo

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-01-01
• Completion: 2009-06-01
• First posted: 2006-12-04
• Last updated: 2013-07-19
• Results posted: 2010-12-31

Locations

1 site across 1 country: United States