The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Banner Health Research Institute
Phoenix, Arizona, United States
Neurological Institute
Phoenix, Arizona, United States
The Parkinson's and Movement Disorder Institute
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Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.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.
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Fountain Valley, California, United States
UCLA/Jules Stein Eye Institute
Los Angeles, California, United States
McKnight Brain Institute
Gainesville, Florida, United States
Plastic Eye Surgery Association
Pensacola, Florida, United States
Rush Presbyterian/St Luke's Medical Center
Chicago, Illinois, United States
Kellogg Eye Center
Ann Arbor, Michigan, United States
Columbia-Presbyterian Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 4 more locations