engleski

A multicentre, double-blind, randomised, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of migraine headaches

BACKGROUND: There is an unmet medical need for safe, effective migraine prophylaxis. BoNTA is well-tolerated and may be effective as migraine prophylaxis. OBJECTIVE: To evaluate the safety and efficacy of BoNTA compared with placebo (PBO) for prophylaxis of episodic migraine. DESIGN AND METHODS: An 11-month, double-blind, randomized, placebo-controlled study required daily record of headache symptoms and acute medication use with an electronic diary. Patients were screened during a 30-day period ; patients with >3 migraines and <16 headache-days entered a single-blind 30-day PBO run-in. Patients were randomized within PBO responder or non-responder (PNR) strata to PBO, 225, 150, or 75 units (U) of BoNTA (BOTOXŇ: Allergan, Inc, Irvine, CA) or PBO using a fixed-site, fixed-dose paradigm for 3 treatments at 90 days intervals. The primary efficacy endpoint was the mean change from baseline in migraine frequency between day 150 and day 180 in the PNR stratum. Adverse events (AEs) were recorded. RESULTS: 954 patients screened ; 495 (322 PNR ; 87.9% female ; mean age, 43.2 years) randomized to BoNTA or PBO. All groups improved, with no significant differences favoring BoNTA. Day 180 PNR mean change in the frequency of migraine headache episodes was – 1.4, – 1.6, – 1.7 and – 1.5 (from a baseline of 4.4, 4.3, 4.7 and 4.7) for PBO, BoNTA 225 U, 150 U and 75 U respectively. The majority of treatment-related AEs were transient and mild to moderate with 31% and 63-67% of patients experiencing them in the PBO and BoNTA groups, respectively (P<0.001). Only 2.8% discontinued the study due to AEs. CONCLUSIONS: BoNTA treatment was safe and well tolerated. Both BoNTA and PBO treated groups showed substantial reductions in the frequency of migraine headache episodes. No statistically significant differences were seen among groups. Frequent acute medication use may have confounded the results.

Migraine ; prohpylaxis ; botulinum toxin

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