Sodium valproate in migraine without aura and medication overuse headache

A randomized controlled trial

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, Elisabetta Pupillo, Cesare Iani, Maria Pia Prudenzano, Marina Diomedi, Antonio Russo & 7 others Giuseppe Veneziano, Laura Rosa Pisani, Giulia Misaggi, Laura Di Clemente, Francesca Puledda, Simona Guerzoni, Marta Allena

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Objective: To assess the efficacy, safety and tolerability of sodium valproate (800. mg/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 (800. mg/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.

Original languageEnglish
Pages (from-to)1289-1297
Number of pages9
JournalEuropean Neuropsychopharmacology
Volume24
Issue number8
DOIs
Publication statusPublished - 2014

Fingerprint

Secondary Headache Disorders
Migraine without Aura
Valproic Acid
Randomized Controlled Trials
Placebos
Safety
Logistic Models
Migraine Disorders
Headache
Comorbidity
Outpatients
Therapeutics
Observation

Keywords

  • Migraine prophylaxis
  • MOH
  • Sodium valproate

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health
  • Pharmacology (medical)
  • Biological Psychiatry
  • Neurology
  • Pharmacology
  • Medicine(all)

Cite this

Sodium valproate in migraine without aura and medication overuse headache : A randomized controlled trial. / Sarchielli, Paola; Messina, Paolo; Cupini, Letizia M.; Tedeschi, Gioacchino; Di Piero, Vittorio; Livrea, Paolo; Pini, Luigi A.; Bernardi, Giorgio; Bono, Giorgio; Sandrini, Giorgio; Caproni, Stefano; Corbelli, Ilenia; Pisani, Francesco; Beghi, Ettore; Calabresi, Paolo; Pupillo, Elisabetta; Iani, Cesare; Prudenzano, Maria Pia; Diomedi, Marina; Russo, Antonio; Veneziano, Giuseppe; Pisani, Laura Rosa; Misaggi, Giulia; Clemente, Laura Di; Puledda, Francesca; Guerzoni, Simona; Allena, Marta.

In: European Neuropsychopharmacology, Vol. 24, No. 8, 2014, p. 1289-1297.

Research output: Contribution to journalArticle

Sarchielli, P, Messina, P, Cupini, LM, Tedeschi, G, Di Piero, V, Livrea, P, Pini, LA, Bernardi, G, Bono, G, Sandrini, G, Caproni, S, Corbelli, I, Pisani, F, Beghi, E, Calabresi, P, Pupillo, E, Iani, C, Prudenzano, MP, Diomedi, M, Russo, A, Veneziano, G, Pisani, LR, Misaggi, G, Clemente, LD, Puledda, F, Guerzoni, S & Allena, M 2014, 'Sodium valproate in migraine without aura and medication overuse headache: A randomized controlled trial', European Neuropsychopharmacology, vol. 24, no. 8, pp. 1289-1297. https://doi.org/10.1016/j.euroneuro.2014.03.010
Sarchielli, Paola ; Messina, Paolo ; Cupini, Letizia M. ; Tedeschi, Gioacchino ; Di Piero, Vittorio ; Livrea, Paolo ; Pini, Luigi A. ; Bernardi, Giorgio ; Bono, Giorgio ; Sandrini, Giorgio ; Caproni, Stefano ; Corbelli, Ilenia ; Pisani, Francesco ; Beghi, Ettore ; Calabresi, Paolo ; Pupillo, Elisabetta ; Iani, Cesare ; Prudenzano, Maria Pia ; Diomedi, Marina ; Russo, Antonio ; Veneziano, Giuseppe ; Pisani, Laura Rosa ; Misaggi, Giulia ; Clemente, Laura Di ; Puledda, Francesca ; Guerzoni, Simona ; Allena, Marta. / Sodium valproate in migraine without aura and medication overuse headache : A randomized controlled trial. In: European Neuropsychopharmacology. 2014 ; Vol. 24, No. 8. pp. 1289-1297.
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T1 - Sodium valproate in migraine without aura and medication overuse headache

T2 - A randomized controlled trial

AU - Sarchielli, Paola

AU - Messina, Paolo

AU - Cupini, Letizia M.

AU - Tedeschi, Gioacchino

AU - Di Piero, Vittorio

AU - Livrea, Paolo

AU - Pini, Luigi A.

AU - Bernardi, Giorgio

AU - Bono, Giorgio

AU - Sandrini, Giorgio

AU - Caproni, Stefano

AU - Corbelli, Ilenia

AU - Pisani, Francesco

AU - Beghi, Ettore

AU - Calabresi, Paolo

AU - Pupillo, Elisabetta

AU - Iani, Cesare

AU - Prudenzano, Maria Pia

AU - Diomedi, Marina

AU - Russo, Antonio

AU - Veneziano, Giuseppe

AU - Pisani, Laura Rosa

AU - Misaggi, Giulia

AU - Clemente, Laura Di

AU - Puledda, Francesca

AU - Guerzoni, Simona

AU - Allena, Marta

PY - 2014

Y1 - 2014

N2 - Objective: To assess the efficacy, safety and tolerability of sodium valproate (800. mg/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 (800. mg/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.

AB - Objective: To assess the efficacy, safety and tolerability of sodium valproate (800. mg/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 (800. mg/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.

KW - Migraine prophylaxis

KW - MOH

KW - Sodium valproate

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