Who is sponsoring NCT00406367?

NCT00406367 is sponsored by Merz Pharmaceuticals GmbH.

What condition does NCT00406367 study?

NCT00406367 studies Blepharospasm.

What drugs are being tested in NCT00406367?

Interventions: incobotulinumtoxinA (Xeomin), Placebo.

What is the status of NCT00406367?

NCT00406367 is currently COMPLETED.

Last reviewed 2013-03-13 · How we verify

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

NCT00406367 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Merz Pharmaceuticals GmbH
Phase	Phase 3
Status	COMPLETED
Enrolment	109
Start date	2006-10
Completion	2009-07

Conditions

Blepharospasm

Interventions

incobotulinumtoxinA (Xeomin)
Placebo

Primary outcomes

Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) — Baseline, week 6
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

Countries

United States, Canada