Levetiracetam was more effective than placebo for decreasing both frequency and intensity of migraine episodes in pediatric patients over a 12-week period, according to a study published in Cephalgia. Side effects were not significant and all of them resolved during the study.
The broad-spectrum, anti-seizure drug levetiracetam has been suggested as effective for migraine prevention in adults. This double-blind randomized placebo-controlled trial was performed to assess the efficacy and safety of this medication in pediatric patients with migraine ages 4 to 17. All participants were patients treated at the Children’s Medical Center, which is a major referral hospital aﬃliated with Tehran University of Medical Sciences. Participants had at least 4 migraine episodes per month or had episodes that were severely disabling or intolerable. Primary end points were mean change in monthly frequency and intensity of episodes from baseline to the last month in the double-blind phase (12 weeks). Adverse effects reported were used to determine safety end point.
Among the 61 participants completing the study, 31 were taking levetiracetam and 30 were taking placebo. All participants experienced reductions in frequency and intensity of migraine episodes, but reductions experienced by participants taking levetiracetam were significantly greater than those taking placebo. This effect remained significant after using the analysis of covariance sensitivity analysis (mean diﬀerence in migraine frequency: -2.84; 95% CI, -4.52 to -1.17; mean diﬀerence in migraine intensity: -1.68; 95% CI, -2.95 to -0.41). In the levetiracetam arm, 17 participants (50%) experienced an over 50% reduction in migraine episodes at 4 weeks, 19 participants (56%) after 8 weeks, and 21 participants (62%) after 12 weeks, with 6 participants reporting complete headache elimination. In the placebo arm, 6 participants (18%) experienced an over 50% reduction in migraine episodes at 4 weeks, 8 participants (24%) after 8 weeks, and 9 participants (26%) after 12 weeks, with 1 participant reporting complete headache elimination. Overall, the levetiracetam arm reported a greater than 50% reduction in headaches among 68% of participants, compared with 30% in the placebo arm (P =.007). Eight individuals taking levetiracetam experienced adverse effects, none of which were significant or led to discontinuation, compared with no adverse effects in the placebo arm. Side effects reported were mild tic (2 cases), daytime sedation (2 cases), and irritability (4 cases), and all of these resolved during treatment.
Limitations of this study included the small sample size, short follow-up period, and a lack of an active comparator. Outcomes were also reported by participants or their parents, which could have led to bias.
Study investigators concluded that levetiracetam was more effective than placebo in decreasing frequency and intensity of migraine episodes in pediatric patients within a 12-week time period, and that future studies with larger sample sizes, longer follow-up periods, and active comparators should be performed.
Please see original reference for a full list of authors’ disclosures.
Montazerlotfelahi H, Amanat M, Tavasoli AR, et al. Levetiracetam for prophylactic treatment of pediatric migraine: A randomized double-blind placebo-controlled trial [published online June 1, 2019]. Cephalalgia. doi: 10.1177/0333102419851814