Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00234507|
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : April 13, 2006
|Condition or disease||Intervention/treatment||Phase|
|Blepharospasm||Drug: Botulinum toxin type A (Dysport®)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||January 2003|
|Study Completion Date :||May 2004|
U.S. FDA Resources
- The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.
- 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- Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234507
|United States, Arizona|
|Banner Health Research Institute|
|Phoenix, Arizona, United States, 85006|
|Phoenix, Arizona, United States, 85013|
|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|
|Study Director:||Jean-Loic Robin, MD||Ipsen|