trokendi xr approved for migraine treatment

Topiramate Efficacy

Topiramate is a highly effective molecule for migraine prevention1-3

Significant reductions in migraine frequency beginning at 100 mg total daily dose1-3

topiramate decrease in migraine frequency study

Study design1,2:
Two multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials were conducted to establish the effectiveness of immediate-release topiramate in the prophylactic treatment of migraine headache. Study 1 was conducted in the US and Study 2 was conducted in the US and Canada. The design of both trials was identical, enrolling patients 12 years to 65 years of age with a history of migraine, with or without aura, for at least 6 months, according to the IHS diagnostic criteria.

Patients were excluded from the trials if they experienced headaches other than migraine, episodic tension, or sinus headaches. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. Patients who experienced 3 to 12 migraine headaches over a 28 day prospective baseline phase were randomized to either topiramate 50 mg/day, 100 mg/day, 200 mg/day, or placebo, and treated for a total of 26 weeks (8-week titration period and 18-week maintenance period). Treatment was initiated at 25 mg/day for one week, and then the daily dosage was increased by 25 mg increments each week until reaching the assigned target dose or maximum tolerated dose (administered twice daily). Effectiveness of treatment was assessed by the reduction in migraine headache frequency, as measured by the change in 4-week migraine rate (according to migraine classified by IHS criteria) from the baseline phase to double-blind treatment period in each topiramate treatment group, compared to placebo, in the intent-to-treat population.

100 mg is the recommended total daily dose of topiramate.1,2,5

Secondary endpoints included monthly acute rescue medication days and mean severity1,2

Monthly acute rescue medication days decreased significantly for patients treated with topiramate 100 mg/day (from 5.9 ± 2.5 to 4.0 ± 3.4; P=.005) or 200 mg/day (from 6.1 ± 2.6 to 4.0 ± 2.8; P=.002) vs placebo (from 6.1 ± 3.0 to 5.2 ± 3.3), but not for those treated with topiramate 50 mg/day (from 5.8 ± 2.5 to 4.5 ± 3.1; P=.12)”†1

Stephen D. Silverstein, MD
Professor of Neurology,
Thomas Jefferson University

There was a statistically significant difference in mean migraine severity between placebo and the topiramate 100 mg/day group (P=.04), but not between the placebo and the topiramate 50 mg/day (P=.61) or 200 mg/day (P=.46) groups.Ӡ2

Jan L. Brandes, MD
Director and Founde of the Nashville Neuroscience Group and Assistant Clinical Professor in the Department of Neurology at Vanderbilt University School of Medicine

Overall discontinuation rates of immediate-release topiramate in placebo-controlled migraine trials

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