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A Placebo Controlled Trial of Flunarizine in Migraine Prophylaxis

A previous open trial of flunarizine in the united States suggested that flunarizine may be useful in migraine prophylaxis (1). Previous controlled trials of flunarizine have been reported from outside the united States. This was the first double blind, placebo-controlled parallel trial of flunarizine 10 mg per day for the prophylaxis of migraine headache in the united States. Of the 143 patients entered into the study, 101 evaluable patients were obtained. All had migraine occurring 2 to 8 times per month for at least 3 months. All had a history of migraine for at least 2 years. Prophylactic medications were discontinued 3 months prior to study entry. None of the patients had a history of previous drug treatment failure for migraine. Patients were randomized to placebo or flunarizine. The trial consisted of a 4 week placebo lead in, followed by 16 weeks of active treatment. Patients were seen every 4 weeks during the course of the study. Appropriate examinations and safety evaluations were conducted prior to and every four weeks during the study. Among the evaluable patients there were 51 treated with placebo and 50 with flunarizine. Migraine with aura was the diagnosis in 17 of the flunarizine patients and in 16 placebo patients. The remainder of the patients had migraine without aura. None of the patients had a significant history of tension-type headaches. The average history of migraine was 17.2 years for active treatment and 17 years for placebo. The flunarizine patients had 4.2 migraines average during baseline and placebo patients had 4.4 attacks. There were 13 males in both the placebo and active treatment groups. The frequency of headaches decreased from 4.2 attacks per month during the baseline period to 1.9 attacks per month