Cyclandelate in the prophylaxis of migraine: a placebo-controlled study

The prophylactic action of cyclandelate was investigated in a multicentre, randomized, placebo-controlled, parallel group study. A 4-week baseline per iod was followed by a 4-week placebo phase and a 16-week treatment period w ith either 1600 mg cyclandelate or placebo. Patients (n=251) with two to si x migraine attacks/month were randomized. Neither the primary study endpoin t (reduction of migraine days from baseline to the last 28 days) nor most o f the secondary endpoints (reduction in the number of migraine attacks, sev erity or duration of attacks, frequency of autonomic disturbances, medicati on for treatment of attacks) showed a difference between cyclandelate and p lacebo. Cyclandelate, however, was superior to placebo in a global impressi on of efficacy rated by the patients and the treating physicians. Both trea tments were well tolerated. In conclusion, cyclandelate was not superior to placebo in the prophylaxis of migraine with regard to parameters usually u sed in migraine prophylaxis trials.