Clinical Trial: IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Treatmen

Brief 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.

Detailed Summary:
Sponsor: Merz Pharmaceuticals GmbH

Current Primary Outcome: Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) [ Time Frame: 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.


Original Primary Outcome: Jankovic Rating Scale

Current Secondary Outcome:

  • Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) [ Time Frame: 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.
  • Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection [ Time Frame: Baseline, week 6 ]
    The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
  • Patient Evaluation of Global Response (PEGR) at Final Visit [ Time Frame: Final visit (up to week 20 after injection of the Main Period) ]
    The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).


Original Secondary Outcome: Jankovic Rating Scale subscores

Information By: Merz Pharmaceuticals GmbH

Dates:
Date Received: November 30, 2006
Date Started: October 2006
Date Completion:
Last Updated: March 13, 2013
Last Verified: March 2013