Clinical trial NCT00234507: Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharospasm
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
measure: PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
measure: Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.
measure: 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.
measure: Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
measure: Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.
measure: Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.
measure: 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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Neurological Institute
state: Arizona
city: Fountain Valley
country: United States
facility: The Parkinson's and Movement Disorder Institute
state: California
city: Los Angeles
country: United States
facility: UCLA/Jules Stein Eye Institute
state: California
city: Gainesville
country: United States
facility: McKnight Brain Institute
state: Florida
city: Pensacola
country: United States
facility: Plastic Eye Surgery Association
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian/St Luke's Medical Center
state: Illinois
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
city: New York
country: United States
facility: Columbia-Presbyterian Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ophthlamic Surgeons and Consultants of Ohio, Inc
state: Ohio
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Parkinson's Disease Center and Movement Disorders Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Center for Facial Appearances
state: Utah
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References: