Topiramate for migraine prevention in adolescents: a pooled analysis of efficacy and safety.
OBJECTIVE
To characterize the efficacy and safety of topiramate for migraine prevention in adolescents from 3 randomized, 26-week, double-blind, placebo-controlled trials.


BACKGROUND
Limited information is available regarding the efficacy and safety of prophylactic medications for treatment of adolescent migraine, a significant health problem. In studies that included adults and children, topiramate 100 and 200 mg/day were effective and generally well-tolerated in the prevention of migraine headache.


METHODS
We performed a post hoc subset analysis of the efficacy and safety data from the 51 patients, ages 12-17 years, enrolled in 3 pivotal trials of topiramate for migraine prophylaxis.


RESULTS
Daily treatment with topiramate 50, 100, and 200 mg for 26 weeks reduced monthly migraine frequency from baseline 46% (P= .07), 63% (P= .02), and 65% (P= .04), respectively, compared with placebo (16%). Similarly, topiramate reduced both the monthly mean number of migraine days (1, 4, and 5 days for topiramate 50, 100, and 200 mg/day, respectively, vs 1 day for placebo) and percentage of days during which acute migraine medications were administered (59%, 54%, and 67% for topiramate 50, 100, and 200 mg/day, respectively, vs 42% for placebo), although the treatment differences did not reach nominal statistical significance. Topiramate 200 mg/day did not appear to offer greater efficacy than 100 mg/day. Treatment was generally well-tolerated, although adverse events were most frequent in the 200 mg/day dose group.


CONCLUSIONS
This post hoc subset analysis suggests that topiramate 100 and 200 mg/day, and possibly 50 mg/day, administered prophylactically for 26 weeks may reduce migraine in adolescents.
Winner
Paul
P
Palm Beach Headache Center, West Palm Beach, FL, USA.
Gendolla
Astrid
A
Stayer
Catherine
C
Wang
Steven
S
Yuen
Eric
E
Battisti
Wendy P
WP
Nye
Jeffrey S
JS
D000293:Adolescent; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000517:prevention & control*; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077236:Topiramate
D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose