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

Primary Purpose

Blepharospasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharospasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Health Research Institute
  • Neurological Institute
  • The Parkinson's and Movement Disorder Institute
  • UCLA/Jules Stein Eye Institute
  • McKnight Brain Institute
  • Plastic Eye Surgery Association
  • Rush Presbyterian/St Luke's Medical Center
  • Kellogg Eye Center
  • Columbia-Presbyterian Medical Center
  • Duke University Medical Center
  • Ophthlamic Surgeons and Consultants of Ohio, Inc
  • Wills Eye Hospital
  • Parkinson's Disease Center and Movement Disorders Clinic
  • Center for Facial Appearances

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
October 5, 2005
Last Updated
July 25, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00234507
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 25, 2004 (Actual)
Study Completion Date
May 25, 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
Title
PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
Title
Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.
Title
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.
Title
Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
Title
Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.
Title
Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Study Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Banner Health Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
The Parkinson's and Movement Disorder Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
UCLA/Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
McKnight Brain Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Plastic Eye Surgery Association
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Rush Presbyterian/St Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Columbia-Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Ophthlamic Surgeons and Consultants of Ohio, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Parkinson's Disease Center and Movement Disorders Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Facial Appearances
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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