• Paola Sarchielli, Paolo Messina, Letizia M Cupini, Gioacchino Tedeschi, Vittorio Di Piero, Paolo Livrea, Luigi A Pini, Giorgio Bernardi, Giorgio Bono, Giorgio Sandrini, Stefano Caproni, Ilenia Corbelli, Francesco Pisani, Ettore Beghi, Paolo Calabresi, and SAMOHA Study Group.
• Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy. Electronic address: paola.sarchielli@gmail.com.
• Eur Neuropsychopharmacol. 2014 Aug 1; 24 (8): 1289-97.

ObjectiveTo assess the efficacy, safety and tolerability of sodium valproate (800mg/die) compared with placebo in medication-overuse headache patients with a history of migraine without aura.MethodsThis is a multicenter, randomized, double-blind, placebo-controlled study enrolled medication-overuse headache patients for a 3-month treatment period with sodium valproate (800mg/day) or placebo after a 6 day outpatient detoxification regimen, followed by a 3-month follow-up. Primary outcome was defined by the proportion of patients achieving ≥50% reduction in the number of days with headache per month (responders) from the baseline to the last 4 weeks of the 3-month treatment. Multivariate logistic regression models were used on the primary endpoint, adjusting for age, sex, disease duration, comorbidity and surgery. The last-observation-carried-forward method was used to adjust for missing values.ResultsNine sites enrolled 130 patients and, after a 6-day detoxification phase, randomized 88 eligible patients. The 3-month responder rate was higher in the sodium valproate (45.0%) than in the placebo arm (23.8%) with an absolute difference of about 20% (p=0.0431). Sodium valproate had safety and tolerability profiles comparable to placebo.ConclusionsThe present study supports the efficacy and safety of sodium valproate in the treatment of medication overuse headache with history of migraine after detoxification.Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

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