Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
- Conditions
- Blepharospasm
- Registration Number
- NCT00234507
- Lead Sponsor
- Ipsen
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- patients with a confirmed diagnosis of bilateral benign essential blepharospasm, and having symptoms of such for at least 6 months prior to the baseline visit
- naïve patients to botulinum toxin type A treatment, or patients who had received a single treatment of botulinum toxin type A, or those who had demonstrated a satisfactory response, in the investigator's opinion, to the last 2 injections of botulinum toxin type A with a minimum of 12 weeks since the last injection and where a further injection at full dosage was now indicated
- patients with a minimum score of 8 on the BDS
- patients with either neuroleptic-induced blepharospasm, isolated levator dysfunction or apraxia
- previous surgical, chemical and thermal myectomy or neurectomy
- any condition where intramuscular injection is contraindicated
- ophthalmolgical infection
- myasthenia gravis or other disorders of the neuromuscular junction
- prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission, or medication where the dose or choice of medication has not been constant for the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study. 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. 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. Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment. Patient assessment of benefit and need for re-treatment, evaluated at the end of the study. Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (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. PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
Trial Locations
- Locations (14)
Neurological Institute
🇺🇸Phoenix, Arizona, United States
Plastic Eye Surgery Association
🇺🇸Pensacola, Florida, United States
Columbia-Presbyterian Medical Center
🇺🇸New York, New York, United States
Rush Presbyterian/St Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Ophthlamic Surgeons and Consultants of Ohio, Inc
🇺🇸Columbus, Ohio, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Center for Facial Appearances
🇺🇸Salt Lake City, Utah, United States
Banner Health Research Institute
🇺🇸Phoenix, Arizona, United States
McKnight Brain Institute
🇺🇸Gainesville, Florida, United States
Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Parkinson's Disease Center and Movement Disorders Clinic
🇺🇸Houston, Texas, United States
The Parkinson's and Movement Disorder Institute
🇺🇸Fountain Valley, California, United States
UCLA/Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States