NCT00406367

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Blepharospasm

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.

Conditions

• Blepharospasm

Interventions

Type	Name	Description
DRUG	incobotulinumtoxinA (Xeomin)	incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection
DRUG	Placebo	Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-04-01
• Completion: 2009-07-01
• First posted: 2006-12-04
• Last updated: 2013-03-15
• Results posted: 2010-11-16

Locations

2 sites across 2 countries: United States, Canada