Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
This study has been completed.
Information provided by:
First received: October 5, 2005
Last updated: April 12, 2006
Last verified: April 2006
The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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 Dysport (40 Units/Eye, 80 Units/Eye, and 120 Units/Eye) for the Treatment of Benign Essential Blepharospasm|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Ipsen:
Primary Outcome Measures:
- The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.
Secondary Outcome Measures:
- 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- Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.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.
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||May 2004|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234507
|United States, Arizona|
|Phoenix, Arizona, United States, 85013|
|Banner Health Research Institute|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|The Parkinson's and Movement Disorder Institute|
|Fountain Valley, California, United States, 92708|
|UCLA/Jules Stein Eye Institute|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|McKnight Brain Institute|
|Gainesville, Florida, United States, 32610|
|Plastic Eye Surgery Association|
|Pensacola, Florida, United States, 32504|
|United States, Illinois|
|Rush Presbyterian/St Luke's Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Michigan|
|Kellogg Eye Center|
|Ann Arbor, Michigan, United States, 48105|
|United States, New York|
|Columbia-Presbyterian Medical Center|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|United States, Ohio|
|Ophthlamic Surgeons and Consultants of Ohio, Inc|
|Columbus, Ohio, United States, 43215|
|United States, Pennsylvania|
|Wills Eye Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Parkinson's Disease Center and Movement Disorders Clinic|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Center for Facial Appearances|
|Salt Lake City, Utah, United States, 84102|
Sponsors and Collaborators
|Study Director:||Jean-Loic Robin, MD||Ipsen|