Levetiracetam in migraine prophylaxis: a randomized placebo-controlled study in a rural medical institute in northern India.
Archana Verma, Dhiraj Srivastava, Alok Kumar, Vineeta Singh
*Departments of Neurology, †SPM, ‡Forensic Medicine and Toxicology, UP Rural Institute of Medical Sciences and Research, Saifai, Etawah, Uttar Pradesh, India; and §Department of Neurology, University of California, San Francisco, San Francisco, CA.
Clinical neuropharmacology. 2013 Nov-Dec;36(6);193-7. doi: 10.1097/WNF.0000000000000005.
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.
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.
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.
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.