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

Completed · Phase 2

Conditions studied: Blepharospasm

In brief

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

Key facts

Study ID

NCT00234507

Run by

Ipsen

People needed

120

Starts

2003-01-01

Expected to finish

2004-05-25

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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