• Daniele Mei, Diana Ferraro, Giovanni Zelano, Alessandro Capuano, Catello Vollono, Carbone Gabriele, and Girolamo Di Trapani.
• Department of Neuroscience, Headache Centre, Catholic University, Rome, Italy. dmei@rm.unicatt.it
• Clin Neuropharmacol. 2006 Sep 1;29(5):269-75.

ObjectiveThis is a randomized, double-blind versus placebo study aimed at evaluating the efficacy of topiramate (TPM) in reducing the number of days with headache and the amount of acute medication taken monthly in patients with chronic migraine with medication overuse. We also studied the efficacy of single triptans available in Italy in interrupting headache crises during preventive treatment.MethodsThe studied sample was made up of 50 subjects: 30 patients were randomized for treatment with TPM, 100 mg/d, and 20 for placebo. Subjects treated with TPM were further randomized to evaluate, in double-blind versus placebo, the efficacy of single triptans available in Italy. The double-blind phase consisted of a titration phase (4 weeks) and of a maintenance phase (8 weeks).Outcome MeasuresThe reduction in the number of days with headache per 28 days and the reduction in the amount of acute medication taken per 28 days throughout the clinical trial in the TPM group were compared with those of the placebo group; the number of patients who were pain-free at 2 hours after the triptan intake and the headache recurrence rate in the 22 hours after the pain-free condition in the triptan group were compared with those of the placebo group. We also looked at tolerability profile.ResultsThe group treated with TPM had a significant reduction in the number of days with headache (P < 0.0001 vs placebo) and in the mean amount of acute medication taken (P < 0.0001 vs placebo); all triptans were superior to placebo; there were no significant differences between different triptans; the analgesic effect of triptans increased throughout the trial.ConclusionsTopiramate proved to be well tolerated and effective in reverting chronic migraine with medication overuse to episodic migraine.

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