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Trial record 7 of 7 for:    "Blepharospasm, Benign Essential" | "Neuromuscular Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234507
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : July 29, 2019
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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.

Condition or disease Intervention/treatment Phase
Blepharospasm Biological: Botulinum toxin type A Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2003
Actual Primary Completion Date : May 25, 2004
Actual Study Completion Date : May 25, 2004

Intervention Details:
  • Biological: Botulinum toxin type A
    Other Name: AbobotulinumtoxinA (Dysport®)

Primary Outcome Measures :
  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 Outcome Measures :
  1. Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
  2. PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
  3. Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.
  4. 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.
  5. Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
  6. Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.
  7. Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.
  8. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234507

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

Layout table for additonal information Identifier: NCT00234507     History of Changes
Other Study ID Numbers: Y-47-52120-706
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Neuromuscular Agents
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Peripheral Nervous System Agents