Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
Information source: Ipsen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blepharospasm
Intervention: Botulinum toxin type A (Dysport®) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Jean-Loic Robin, MD, Study Director, Affiliation: Ipsen
Summary
The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo
by assessing functional disability in blepharospasm.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
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 Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Neurological Institute, Phoenix, Arizona 85013, United States
Banner Health Research Institute, Phoenix, Arizona 85006, United States
UCLA/Jules Stein Eye Institute, Los Angeles, California 90095, United States
The Parkinson's and Movement Disorder Institute, Fountain Valley, California 92708, United States
McKnight Brain Institute, Gainesville, Florida 32610, United States
Plastic Eye Surgery Association, Pensacola, Florida 32504, United States
Rush Presbyterian/St Luke's Medical Center, Chicago, Illinois 60612, United States
Kellogg Eye Center, Ann Arbor, Michigan 48105, United States
Columbia-Presbyterian Medical Center, New York, New York 10032, United States
Duke University Medical Center, Durham, North Carolina 27705, United States
Ophthlamic Surgeons and Consultants of Ohio, Inc, Columbus, Ohio 43215, United States
Wills Eye Hospital, Philadelphia, Pennsylvania 19107, United States
Parkinson's Disease Center and Movement Disorders Clinic, Houston, Texas 77030, United States
Center for Facial Appearances, Salt Lake City, Utah 84102, United States
Additional Information
Starting date: January 2003
Ending date: May 2004
Last updated: April 12, 2006
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