Levetiracetam in migraine prophylaxis: a randomized placebo-controlled study in a rural medical institute in northern India.

OBJECTIVE

Migraine is often a chronic and disabling disorder. The objective of our study was to assess the efficacy and tolerability of levetiracetam (LEV) in adult migraine prophylaxis.

METHODS

We conducted a prospective, randomized, placebo-controlled study. A total of 65 patients were randomized in a 1:1 ratio to receive LEV (n = 32) or placebo (n = 33). Twenty-five patients completed the study in the LEV group and 27 patients in the placebo group. Thirteen subjects discontinued early during the trial. After a 1-month run in period, LEV was started at a dose of 250 mg/d (or the matching placebo) and was increased by 250 mg/wk until the final dosage of 1000 mg/d was reached. The titration phase was followed by maintained phase of 3 months.

RESULTS

In LEV group, we found a significant reduction in the frequency (attacks per month) of migraine (from 5.17 [SD, 1.19] at baseline to 2.21 [1.47] in the last 4 weeks) and also in severity of migraine from (2.75 [0.44] to1.29 [0.75]) as compared to the placebo group. Patients treated with LEV also reported a statistically significant reduction in the quantity of symptomatic drugs needed for symptom control as compared to the placebo group (P < 0.0001). The percentage of patients on LEV who experienced greater than or equal to 50% reduction in headache frequency was 64% compared with 22% for placebo.

CONCLUSIONS

Compared with the placebo group, LEV offers improvement in headache frequency and severity as well as it lowers the requirement for other symptomatic drugs in adult migraine patients.