Flunarizine (Sibelium) in the prophylaxis of migraine. An open, long-term, multicenter trial.

Sixty-four Spanish neurological centers participated in a study designed to evaluate the efficacy and safety of flunarizine in migraine. One thousand four hundred and thirty-five outpatients (367 [25.6%] males and 1,068 [74.4%] females) fulfilling the criteria proposed by the International Headache Society for the diagnosis of migraine entered the study. Patients were treated with 10 mg of single-dose flunarizine (Sibelium) alone at bedtime in open fashion for 6 months. At the end of this treatment period, flunarizine was withdrawn, but the follow-up of the patients continued for another 6 months. The evaluation criteria used were a rating scale (the GES) based on frequency, duration, intensity, and characteristics of the attacks as well as a checklist of possible side-effects. This clinical assessment was recorded in detail in the patients' rating notebooks at the start and at the end of the third, sixth, ninth, and twelfth month of the study. A mean decrease of 66.9% in the GES was obtained at the end of the treatment period, which implies a good or excellent result in the prophylaxis of migraine attacks in 69.5% of the patients. This improvement was practically unchanged at the end of the follow-up period. Side-effects were moderate, the most frequent ones being drowsiness and weight gain. Their incidence decreased after the first months of treatment.