What were the trial designs and inclusion/exclusion criteria for TOPAMAX in the pivotal studies?
TOPAMAX was evaluated for migraine prevention in 2 large, 26-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials. Patients included in these studies were required to have a history of migraine assessed by the International Headache Society (IHS), for at least 6 months prior to screening. 5,6 They had to be between 12 and 70 years of age and experience between 3 and 12 migraines, but not more than 15 headache days (migraine or nonmigraine) during a 28-day prospective baseline period. Patients were excluded if they experienced headaches other than migraine (i.e., episodic tension or sinus headaches). Patients were also excluded if they failed to respond to more than 2 previous regimens of migraine prevention therapy, if their onset of migraine occurred after age 50, or if they overused analgesics or acute medications.
