Topiramate for Migraine Prevention<SUBTITLE>A Randomized Controlled Trial</SUBTITLE>

Abstract

TN 37203 (jbrandes @nashvilleneuroscience.com).Context Small open-label and controlled trials suggest that the antiepileptic drug topiramate is effective for migraine prevention.Objective To assess the efficacy and safety of topiramate for migraine prevention in a large controlled trial. Design, Setting, and PatientsA 26-week, randomized, double-blind, placebocontrolled study was conducted during outpatient treatment at 52 North American clinical centers. Patients were aged 12 to 65 years and had a 6-month history of migraine (International Headache Society criteria) and 3 to 12 migraines a month but no more than 15 headache days a month during a 28-day prospective baseline phase.Interventions After a washout period, patients meeting entry criteria were randomized to topiramate (50, 100, or 200 mg/d) or placebo. Topiramate was titrated by 25 mg/wk for 8 weeks to the assigned or maximum tolerated dose, whichever was less. Patients continued receiving that dose for 18 weeks. Main Outcome MeasuresThe primary efficacy measure was change from baseline in mean monthly migraine frequency. Secondary efficacy measures included responder rate (proportion of patients with Ն50% reduction in monthly migraine frequency), reductions in mean number of monthly migraine days, severity, duration, and days a month requiring rescue medication, and adverse events. The month of onset of preventive treatment action was assessed. ResultsOf 483 patients randomized, 468 provided at least 1 postbaseline efficacy assessment and comprised the intent-to-treat population. Mean monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg/d (−2.1, P=.008) and topiramate at 200 mg/d (−2.4, PϽ.001) vs placebo (−1.1). Statistically significant reductions (PϽ.05) occurred within the first month with topiramate at 100 and 200 mg/d. The responder rate was significantly greater with topiramate at 50 mg/d (39%, P=.01), 100 mg/d (49%, PϽ.001), and 200 mg/d (47%, PϽ.001) vs placebo (23%). Reductions in migraine days were significant for the 100-mg/d (P=.003) and 200-mg/d (PϽ.001) topiramate groups. Rescue medication use was reduced in the 100-mg/d (P=.01) and 200-mg/d (P=.005) topiramate groups. Adverse events resulting in discontinuation in the topiramate groups included paresthesia, fatigue, and nausea.Conclusion Topiramate showed significant efficacy in migraine prevention within the first month of treatment, an effect maintained for the duration of the doubleblind phase.

Clinical Assessment of Topiramate Therapy in Patients With Migrainous Vertigo

“…There are several articles about adverse effects of topiramate and discontinuation rates around 20% have been reported. 24,25 Our results are compatible with the literature. We noticed that encouraging the patients for the usage of the drug and explaining the adverse effects before treatment will reduce the early discontinuation rates.…”

“…Patients in the low‐dose group better complied with the study and tolerated the drug. There are several articles about adverse effects of topiramate and discontinuation rates around 20% have been reported 24,25 . Our results are compatible with the literature.…”

Topiramate in prevention of cluster headache in the Taiwanese

“…Our study suggests that the tolerably rapid titration may be possible in certain patients with excruciating cluster headache for the additional benefi ts. Paresthesia was the fi rst appearance of adverse effects, and occurred frequently in our patients, which is consistent with previous reports of topiramate therapy for cluster headache and migraine, [6,24] but higher than that observed in patients with epilepsy who were treated with topiramate. [15][16][17] While the underlying mechanism remains unclear, it is possible that the activities of carbonic anhydrase are inhibited by rapid titration to high doses of topiramate [25] or this enzyme in the patients with cluster attack becomes more effi cient to react with topiramate.…”

Acupuncture plus topiramate placebo versus topiramate plus sham acupuncture for the preventive treatment of chronic migraine: A single-blind, double-dummy, randomized controlled trial

“…Topiramate is widely recommended in guidelines for the preventive treatment of chronic migraine (10,13,20), demonstrating proven efficacy. In this study, the change from baseline in MMDs with topiramate (2.8 days) aligns with previous trial results (2.3 to 3.5 days) (31,32). For topiramate, the 50% response rate in this study was lower than that in two other placebo-controlled trials (32,33).…”