Quantitative assessment of efficacy of dysport (botulinum toxin type A) in the treatment of idiopathic blepharospasm and hemifacial spasm.

Abstract

This study was a Phase IV, prospective, one arm, non-comparative open trial, to investigate the efficacy and safety of Dysport (Botulinum toxin type A) in patients with idiopathic blepharospasm or hemifacial spasm. During the treatment period, patients were evaluated at baseline (week 0), week 6, and week 8, 10, or 12. Thirty two women and 16 men completed the whole course of the study. The therapeutic efficacy of Dysport became evident from 1.5 to 15 days (mean+/- SD, 6.1 +/- 2.9 days). The maximal effect appeared 12.2+/-5.0 days later. Injection of Dysport achieved 72.9 (13.0% amelioration in the spasm symptom. Dysport significantly improved the following functions, such as reading, watching TV, house work, working, driving and outing alone. At the twelfth week after Dysport injection, it was still effective in relieving blepharospasm or hemifacial spasm. The most frequent adverse event was ptosis, which was noted in 9 cases and represented 18.7% of total patients. Other adverse events were very mild, although lagophthalmos and dry eyes occurred in some patients, but none manifested any corneal complications. In conclusion, Dysport injection appears to be a safe, and effective procedure - accompanied only by minor, and transit adverse events.