Low-dose Topiramate for migraine of persistent preventive medication

Background and Objectives: Migraine, the most common cause of headache. We consequently conducted a single-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of TPM at 50 mg/d for a 3-month total treatment period as prophylactic mono-therapy for refractory migraine. Materials & Methods: 70 Patients were aged 15 to 45 years and had a history of migraine attacks (International Headache Society criteria) for > 1 years with a frequency of at least 1 to 6 attacks per month between Jun 2005-7. Efficacy end points included the proportion of subjects responding to treatment, mean change in monthly frequency and severity of migraine attacks by comparing baseline and migraine status of placebo group for 3 months. Analysis of quantitative data was done by repeated-measure analysis of variance (ANOVA), followed by Newman-Keuls and Spearman’s Coefficient Rank Correlation as the post hoc test. All data were analyzed with the computer program, GRAPHPAD software (V2.01 + ). Results: 66 (94.28%) of the 70 eligible patients completed the trial. The mean age of the patients was 30.33±7.9 years, 48.5% were male, and 51.5% were single. We recorded a significant reduction in the severity of migraine attacks in all months with [F (3, 32) = 13.462, P < 0.0001, NO. = 33] and frequency of migraine attacks [F (3, 32) = 15.203, P < 0.0001, NO. = 33] for TPM group. But we didn’t record any significant reduction in the placebo group. Responder rate for patients treated with TPM was significantly larger than placebo in 3rd Month (63.6%, P<0.0001). Side effects were transient and well tolerated. Conclusion: Low dose of TPM showed significant efficacy in migraine prevention within the first, second, and third month of treatment. Low dose of TPM seems to be a good therapeutic option for the patients with refractory migraine.