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.

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