title: Sodium valproate in migraine without aura and medication overuse headache: a randomized controlled trial.
abstract: OBJECTIVE
  To 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.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  Nine 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.
  
  
  CONCLUSIONS
  The present study supports the efficacy and safety of sodium valproate in the treatment of medication overuse headache with history of migraine after detoxification.
authors.affiliation: Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy. Electronic address: paola.sarchielli@gmail.com.
authors.forename: Paola
authors.initials: P
authors.lastname: Sarchielli
authors.affiliation: IRCCS Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Messina
authors.affiliation: Centro Cefalee e Malattie Cerebrovascolari, Ospedale S. Eugenio, Roma, Italy.
authors.forename: Letizia M
authors.initials: LM
authors.lastname: Cupini
authors.affiliation: Clinica Neurologica, II Università degli Studi di Napoli, Italy.
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Tedeschi
authors.affiliation: Dipartimento di Neurologia e Psichiatria, Università di Roma "La Sapienza", Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Di Piero
authors.affiliation: Clinica Neurologica, Policlinico di Bari, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Livrea
authors.affiliation: Centro Cefalee, Università degli Studi di Modena e Reggio Emilia, Italy.
authors.forename: Luigi A
authors.initials: LA
authors.lastname: Pini
authors.affiliation: Clinica Neurologica, Policlinico Tor Vergata, Roma, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Bernardi
authors.affiliation: Centro Cefalee/Sez. UCADH - Università degli Studi dell׳Insubria, Varese, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Bono
authors.affiliation: IRCCS Fondazione "Istituto Mondino", Università di Pavia, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Sandrini
authors.affiliation: Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Caproni
authors.affiliation: Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy.
authors.forename: Ilenia
authors.initials: I
authors.lastname: Corbelli
authors.affiliation: Clinica Neurologica, Università di Messina, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pisani
authors.affiliation: IRCCS Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Beghi
authors.affiliation: Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy; IRCCS Fondazione "S. Lucia", Roma, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Calabresi
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000704:Analysis of Variance; D018692:Antimanic Agents / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D062787:Drug Overdose / Q000150:complications*; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement; D011788:Quality of Life; D011795:Surveys and Questionnaires; D014635:Valproic Acid / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D018692:Antimanic Agents; D014635:Valproic Acid
keywords: MOH; Migraine prophylaxis; Sodium valproate