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

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

Study Overview

• Status: Completed
• Conditions: Blepharospasm
• Intervention / Treatment: Biological: Botulinum toxin type A

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Health Research Institute
    • Phoenix, Arizona, United States, 85013
      • Neurological Institute
  • California
    • Fountain Valley, California, United States, 92708
      • The Parkinson's and Movement Disorder Institute
    • Los Angeles, California, United States, 90095
      • UCLA/Jules Stein Eye Institute
  • Florida
    • Gainesville, Florida, United States, 32610
      • McKnight Brain Institute
    • Pensacola, Florida, United States, 32504
      • Plastic Eye Surgery Association
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Presbyterian/St Luke's Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Kellogg Eye Center
  • New York
    • New York, New York, United States, 10032
      • Columbia-Presbyterian Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Ophthlamic Surgeons and Consultants of Ohio, Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Parkinson's Disease Center and Movement Disorders Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Center for Facial Appearances

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (ACTUAL): May 25, 2004
• Study Completion (ACTUAL): May 25, 2004

Study Registration Dates

• First Submitted: October 5, 2005
• First Submitted That Met QC Criteria: October 5, 2005
• First Posted (ESTIMATE): October 7, 2005

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharospasm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: Y-47-52120-706