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- Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.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