The impact of migraine on daily activities: effect of topiramate compared with placebo

Objective: Assess the impact of migraine preventive therapy on patient-reported routine daily activities using the Migraine Specific Questionnaire ( MSQ) and the Medical Outcomes Study Short Form-36 ( SF-36) in patients with migraine who participated in a 26-week, randomized, double-blind, placebo-controlled trial of topiramate for migraine prevention. Methods: Patients were required to have 3-12 migraines and <= 15 headache days/month during the baseline phase. Patients who failed > 2 adequate regimens of migraine preventive therapy were excluded. MSQ and SF-36 data were collected at baseline, weeks 8, 16, and 26 from 469 patients receiving either topiramate 50, 100, or 200 mg/day or placebo. Patients entered a double-blind, 8-week titration period followed by an 18-week maintenance period. Two activity-related MSQ domains ( Role Restrictive [ RR] and Role Prevention [ RP]) and two activity-related SF-36 domains ( Role Physical [ SF-36-RP] and Vitality [ SF-36-VT]) were prospectively designated as the outcome measures. Changes in MSQ and SF-36 scores during the double-blind phase relative to prospective baseline scores were compared between topiramate- and placebo-treated groups. Specifically, a mixed-effect piecewise linear regression model was used to estimate average domain score over time, and areas under the domain-over-time curve ( AUC) were compared using a 2-sided t-test, with multiplicity adjustment. Results: In the intent-to-treat population ( N = 469), topiramate ( all doses) significantly improved mean MSQ-RR domain scores versus placebo ( topiramate 50 mg/day, p = 0.035; topiramate 100 mg/day; p < 0.001; topiramate 200 mg/day, p = 0.001). Topiramate-associated improvements in mean MSQ-RP domain scores were significant versus placebo only for topiramate 100 mg/day ( p = 0.045). SF-36-RP and SF-36-VT domain scores improved ( not significant versus placebo) for topiramate 100 and 200 mg/day. Changes in these MSQ and SF-36 domain scores significantly correlated with changes in mean monthly migraine frequency. Conclusion: Improvements in patient-reported outcomes specific for migraine ( measured by the MSQ) were significantly better for patients receiving topiramate than for those receiving placebo. Improvements in the prospectively selected MSQ and SF-36 domains were significantly correlated with the decrease in mean monthly migraine frequency observed with topiramate treatment.