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Abstract
Objective: To evaluate the efficacy, safety, and tolerability of oxcarbazepine (1,200 mg/day) vs placebo as prophylactic therapy for patients with migraine headaches.
Methods: This multicenter, double-blind, randomized, placebo-controlled, parallel-group trial consisted of a 4-week single-blind baseline phase and a 15-week double-blind phase consisting of a 6-week titration period, an 8-week maintenance period, and a 1-week down-titration period, after which patients could enter a 13-week open-label extension phase. During the 6-week titration period, oxcarbazepine was initiated at 150 mg/day and increased by 150 mg/day every 5 days to a maximum tolerated dose of 1,200 mg/day. The primary outcome measure was change from baseline in the number of migraine attacks during the last 28-day period of the double-blind phase.
Results: Eighty-five patients were randomized to receive oxcarbazepine and 85 to receive placebo. There was no difference between the oxcarbazepine (–1.30) and placebo groups in mean change in number of migraine attacks from baseline during the last 28 days of double-blind phase (–1.74; p = 0.2274). Adverse events were reported for 68 oxcarbazepine-treated patients (80%) and 55 placebo-treated patients (65%). The majority of adverse events were mild or moderate in severity. The most common adverse events (≥15% of patients) in the oxcarbazepine-treated group were fatigue (20.0%), dizziness (17.6%), and nausea (16.5%); no adverse event occurred in more than 15% of the placebo-treated patients.
Conclusions: Overall, oxcarbazepine was safe and well tolerated; however, oxcarbazepine did not show efficacy in the prophylactic treatment of migraine headaches.
GLOSSARY: AE = adverse event; AED = antiepileptic drug; ANCOVA = analysis of covariance; CGI = Clinical Global Impressions; GABA = γ-aminobutyric acid; IHS = International Headache Society; ITT = intent-to-treat; IVRS = interactive voice response system; MIDAS = Migraine Disability Assessment Test; NSAIDs = nonsteroidal anti-inflammatory drugs; PGI = Patient Global Impressions; SF-36 = Short Form-36.
Footnotes
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Disclosure: This study was supported by Novartis Pharmaceuticals Corporation. S. Silberstein has received grants for other research or activities not reported in this article and has received honoraria during the course of this study from Novartis Pharmaceuticals Corporation, not in excess of US $10,000 per year. J. Saper has received honoraria from Novartis Pharmaceuticals Corporation, not in excess of US $10,000 per year, during the course of this study for other activities not reported in this article. F. Berenson has received honoraria from Novartis Pharmaceuticals Corporation, not in excess of US $10,000 per year, during the course of this study for other activities not reported in this article. M. Somogyi, K. McCague and J. D’Souza are employees of Novartis Pharmaceuticals Corporation.
Received February 10, 2006. Accepted in final form July 23, 2007.
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