Paola Sarchielli1, Paolo Messina2, Letizia M Cupini3, Gioacchino Tedeschi4, Vittorio Di Piero5, Paolo Livrea6, Luigi A Pini7, Giorgio Bernardi8, Giorgio Bono9, Giorgio Sandrini10, Stefano Caproni11, Ilenia Corbelli11, Francesco Pisani12, Ettore Beghi2, Paolo Calabresi13. 1. Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy. Electronic address: paola.sarchielli@gmail.com. 2. IRCCS Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy. 3. Centro Cefalee e Malattie Cerebrovascolari, Ospedale S. Eugenio, Roma, Italy. 4. Clinica Neurologica, II Università degli Studi di Napoli, Italy. 5. Dipartimento di Neurologia e Psichiatria, Università di Roma "La Sapienza", Italy. 6. Clinica Neurologica, Policlinico di Bari, Italy. 7. Centro Cefalee, Università degli Studi di Modena e Reggio Emilia, Italy. 8. Clinica Neurologica, Policlinico Tor Vergata, Roma, Italy. 9. Centro Cefalee/Sez. UCADH - Università degli Studi dell׳Insubria, Varese, Italy. 10. IRCCS Fondazione "Istituto Mondino", Università di Pavia, Italy. 11. Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy. 12. Clinica Neurologica, Università di Messina, Italy. 13. Clinica Neurologica, Azienda Ospedaliera - Università di Perugia, Italy; IRCCS Fondazione "S. Lucia", Roma, Italy.
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) orplacebo 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.
RCT Entities:
OBJECTIVE: To assess the efficacy, safety and tolerability of sodium valproate (800mg/die) compared with placebo in medication-overuse headachepatients with a history of migraine without aura. METHODS: This is a multicenter, randomized, double-blind, placebo-controlled study enrolled medication-overuse headachepatients 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: David A Seminowicz; Shana A B Burrowes; Alexandra Kearson; Jing Zhang; Samuel R Krimmel; Luma Samawi; Andrew J Furman; Michael L Keaser; Neda F Gould; Trish Magyari; Linda White; Olga Goloubeva; Madhav Goyal; B Lee Peterlin; Jennifer A Haythornthwaite Journal: Pain Date: 2020-03-13 Impact factor: 7.926
Authors: Jeffrey L Jackson; Elizabeth Cogbill; Rafael Santana-Davila; Christina Eldredge; William Collier; Andrew Gradall; Neha Sehgal; Jessica Kuester Journal: PLoS One Date: 2015-07-14 Impact factor: 3.240