Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
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
1 other identifier
interventional
120
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2003
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2004
CompletedFirst Submitted
Initial submission to the registry
October 5, 2005
CompletedFirst Posted
Study publicly available on registry
October 7, 2005
CompletedJuly 29, 2019
July 1, 2019
1.4 years
October 5, 2005
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (14)
Banner Health Research Institute
Phoenix, Arizona, 85006, United States
Neurological Institute
Phoenix, Arizona, 85013, United States
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708, United States
UCLA/Jules Stein Eye Institute
Los Angeles, California, 90095, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Study Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2005
First Posted
October 7, 2005
Study Start
January 1, 2003
Primary Completion
May 25, 2004
Study Completion
May 25, 2004
Last Updated
July 29, 2019
Record last verified: 2019-07