Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00234507

Purpose

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

Condition	Intervention	Phase
Blepharospasm	Drug: Botulinum toxin type A (Dysport®)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Botox

Further study details as provided by Ipsen:

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Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.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.

Estimated Enrollment:	120
Study Start Date:	January 2003
Estimated Study Completion Date:	May 2004

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234507

Locations

United States, Arizona
Neurological Institute
Phoenix, Arizona, United States, 85013
Banner Health Research Institute
Phoenix, Arizona, United States, 85006
United States, California
UCLA/Jules Stein Eye Institute
Los Angeles, California, United States, 90095
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
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

Ipsen

Investigators

Study Director:

Jean-Loic Robin, MD

Ipsen

More Information

No publications provided

Study ID Numbers:	Y-47-52120-706
Study First Received:	October 5, 2005
Last Updated:	April 12, 2006
ClinicalTrials.gov Identifier:	NCT00234507 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Botulinum Toxins
Anti-Dyskinesia Agents
Therapeutic Uses
Eye Diseases
Physiological Effects of Drugs
Eyelid Diseases

Neuromuscular Agents
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents
Blepharospasm
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010