Clinical Trial: Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm

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

Official Title: Phase II, Multi-Centre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection, of Three Doses of Dy

Brief Summary: The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
  • PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
  • Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.
  • Change from baseline in BDS, FIM, severity of oculo-facial spasm and in severity of global impairment due to blepharospasm (measured by VAS) at 4, 8, 12 and 16 weeks post treatment.
  • Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
  • Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.
  • Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.
  • To compare the safety of each of the 3 doses of Dysport with placebo in terms of adverse event incidence, vital signs and physical examinations.


Original Secondary Outcome: Same as current

Information By: Ipsen

Dates:
Date Received: October 5, 2005
Date Started: January 2003
Date Completion: May 2004
Last Updated: April 12, 2006
Last Verified: April 2006