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Topiramate Appears Effective for Prevention of Migraines

Topiramate, an anti-epileptic drug, appears to be effective as a preventative migraine treatment, according to the results of a 26-week, randomised study in the United States.

Stephen D. Silberstein, MD, Jefferson Headache Centre, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, and researchers from the MIGR-001 Study Group found that mean month frequency of migraines decreased significantly for patients who took topiramate, either 100 or 200 mg/day.

The researchers point out that migraines occur in 17% of women, 6% of men and 4% of children. Preventive treatment can become necessary when these migraines interfere with daily routines, despite acute care, or when acute medications fail or are overused.

The study included 487 patients, aged from 12 to 65 years, who were treated at 49 different clinical centres. Participants had an established history of migraine for 6 months or more, with or without aura, using International Headache Society criteria. The subjects experienced from 3 to 12 migraines during the prospective 28-day baseline study phase.

The patients were randomised to 1 of 4 treatment groups: placebo or topiramate at 50, 100 or 200 mg/day, titrated by 25 mg/week to an assigned dose or as tolerated at 8 weeks. Maintenance therapy was continued for 18 weeks.

Patients were examined every 4 weeks during the study period. During these visits, researchers reviewed headache and medication records, as well as weight, vital sign measurements and adverse events. The medication records contained information regarding acute medications taken by the patients. Allowable medications were aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, ergot derivatives and opioids.

Primary efficacy measure was reduction in mean migraine frequency, secondary efficacy was time to onset of action, proportion of subjects responding to treatment, as well as change in monthly migraine days and number of days requiring acute rescue medications.

In the 100-mg/d treatment group, the mean monthly frequency of migraines decreased to 3.3 from 5.4 (P < .001). In the 200-mg/d treatment group, the mean monthly migraine decrease was from 5.6 to 3.3 (P < .001). In the placebo group, the mean monthly decrease was from 5.6 to 4.6 migraines.

Improvements were seen within the first treatment month.

Adverse effects included paraesthesia, fatigue, nausea and loss of appetite, with a higher incidence in the 200 mg/day group.

"Based on its efficacy herein and the tolerability profile established from its use in patients with epilepsy, topiramate should be considered a first-line treatment option for the prevention of migraine headaches," the researchers concluded.



Archives of Neurology 2004;61:490-495.

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