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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 120
• Participant gender: Both

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2006-04-12

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