"Topiramate Effective Headache Prophylaxis in Chronic Migraineurs: Presented at EHF"
By Jill Stein
VALENCIA, SPAIN -- May 2, 2006 -- New data suggest that patients who experience chronic migraine headaches, defined as at least 15 headache days per month, benefit from preventive treatment with topiramate (Topamax[R).
The findings, which were presented on April 27th at the 8th Annual Meeting of the European Headache Federation (EHF), are from the 16-week, TOPiramate in CHROnic MigraineE (TOP-CHROME) study.
The results also showed that topiramate reduced headaches in patients who overused acute medications.
"Although chronic headache is the most common form of seriously disabling headache and preventive treatment is essential for its management, there has been a lack of controlled trials regarding treatment," said co-investigator Hans-Christoph Diener, MD, professor, neurology division, University of Essen, Essen, Germany.
The study included a 4-week baseline observation period without trial medication followed by initiation of treatment with placebo or topiramate at a daily dose of 25 mg. The dose was then increased in weekly 25 mg increments to a target dose of 100 mg/day (with a 200 mg/day maximum dose). Final doses ranged between 50 and 200 mg/day according to patients' individual needs, with a mode dose of 100 mg.
The primary efficacy measure was change in the number of migraine days during the final 4 weeks of treatment in the double-blind phase versus the number of migraine days during the 4-week baseline observation period.
About 75% of subjects were women. The mean age of the cohort was 46 years, and the average number of migraine days during the 4-week baseline phase was 16.
"We were able to reach our primary efficacy endpoint," Dr. Diener said in a poster presentation. That is, the number of migraine days in the last four weeks of treatment dropped by 3.5 in the topiramate group versus no significant change (+0.2) in the placebo group (P =.0203 between groups).
Migraine headaches decreased by one-third (from 15.5 to 10.0 days per 4 weeks) in subjects who completed double-blind treatment with topiramate versus a small increase from 15.3 to 16.0 days per 4 weeks in those treated with placebo.
The study also found that up to 29% of patients in the topiramate group responded to treatment versus up to 4% of placebo patients. Subjects were classified as responders if their number of migraine days decreased by at least 50% in response to their assigned treatment.
While 63% of topiramate-treated subjects had overused acute medications at the start of the trial, only 28% of this group overused acute medications at the end of the trial. Sixty seven percent of placebo patients overused acute medications at the start of the trial versus 59% at the end of the trial.
Patients' scores on the Migraine Disability Assessment Score 2 (MIDAS-2) questionnaire were significantly better in topiramate-treated patients.
Topiramate treatment was generally well tolerated.
Topiramate is a neurostabilizer that is widely used as an anti-epileptic drug. Used at fixed daily doses (50, 100, or 200 mg) for up to 26 weeks, topiramate has also established itself in 3 pivotal trials as an effective treatment for the prevention of episodic migraines.
The study was supported by Janssen-Cilag.
[Presentation title: Assessing the Efficacy and Safety of Topiramate for the Prevention of Chronic Migraine. Abstract 39]
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