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Trileptal Fails Test for Migraine Prevention

by Teri Robert, MyMigraineConnection Lead Expert

Over the last several years, neuronal stabilizing agents (also known as anticonvulsants or epilepsy medications) have been increasingly prescribed for Migraine prevention. Out of the four medications that are actually FDA approved for Migraine prevention, two of them -- Depakote (divalproex) and Topamax (topiramate) -- are neuronal stabilizing agents. It has been thought that these medications are effective for Migraine prevention because they calm overactive neurons in the brains of Migraineurs.

Trileptal (oxcarbazepine) is one medication in this family that has been prescribed off-label for Migraine prevention. A new study has now shown that Trileptal apparently does not work well as a Migraine preventive. The results of this research are published in the February 12, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology.

The study

Study objective: "To evaluate the efficacy, safety, and tolerability of oxcarbazepine (1,200 mg/day) vs. placebo as prophylactic therapy for patients with migraine headaches."

Study methods:

  • Participants were recruited from 23 headache and Migraine treatment centers in the United States.
  • The 170 study participants were randomly assigned to two groups of 85. One group received oxcarbazepine; the other received placebo.
  • Study participants were patients experiencing three to nine Migraine attacks per month.
  • This study was conducted over a period of nearly five months.

Study results:

  • There was no difference between the oxcarbazepine and placebo groups in change in number of migraine attacks from baseline during the last 28 days of double-blind (Neither the researchers nor the participants knew who was receiving oxcarbazepine and who was receiving placebo.) phase.
  • Adverse events (side effects) 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 side effects (15% of patients) in the oxcarbazepine-treated group were fatigue (20.0%), dizziness (17.6%), and nausea (16.5%).
  • No side effect occurred in more than 15% of the placebo-treated patients.
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