Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm

Blepharospasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234507
• Other study ID #: Y-47-52120-706
• Status: Completed
• Phase: Phase 2
• Start date: January 2003
• Est. completion date: May 25, 2004

Study information

• Verified date: July 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 25, 2004
• Est. primary completion date: May 25, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharospasm

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
United States	Kellogg Eye Center	Ann Arbor	Michigan
United States	Rush Presbyterian/St Luke's Medical Center	Chicago	Illinois
United States	Ophthlamic Surgeons and Consultants of Ohio, Inc	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	The Parkinson's and Movement Disorder Institute	Fountain Valley	California
United States	McKnight Brain Institute	Gainesville	Florida
United States	Parkinson's Disease Center and Movement Disorders Clinic	Houston	Texas
United States	UCLA/Jules Stein Eye Institute	Los Angeles	California
United States	Columbia-Presbyterian Medical Center	New York	New York
United States	Plastic Eye Surgery Association	Pensacola	Florida
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Banner Health Research Institute	Phoenix	Arizona
United States	Neurological Institute	Phoenix	Arizona
United States	Center for Facial Appearances	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
Secondary	PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
Secondary	Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.
Secondary	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.
Secondary	Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
Secondary	Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.
Secondary	Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.
Secondary	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.