TUESDAY, Feb. 12 (HealthDay News) -- Prophylactic oxcarbazepine (Trileptal) does not appear to be effective in preventing migraine attacks, according to the results of a study published in the Feb. 12 issue of Neurology.
Stephen D. Silberstein, M.D., of Thomas Jefferson University Hospital in Philadelphia, and colleagues conducted a double-blind, randomized, controlled trial of oxcarbazepine versus placebo in 170 migraine headache patients. The trial consisted of a four-week baseline placebo phase followed by a 15-week double-blind phase, which included a six-week titration period in which the dose of oxcarbazepine was increased as tolerated from 150 mg/day to a maximum dose of 1,200 mg/day. Following the 15-week trial, patients could elect to continue for a 13-week open-label extension phase. The primary outcome measure was change in migraine frequency.
The researchers found that there was no difference in rates of migraine attacks over the baseline rate in oxcarbazepine versus placebo-treated patients. Overall, oxcarbazepine was well tolerated, with the most commonly reported side effects of fatigue, dizziness and nausea.
"While several antiepileptic drugs have been shown to prevent migraine, in this study no difference between the oxcarbazepine and placebo groups was demonstrated for the primary efficacy measure of mean change in number of migraine attacks from baseline during the last 28 days of the double-blind phase," the authors conclude.
This study was funded by Novartis Pharmaceuticals Corporation.
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