Juvenile Myoclonic Epilepsy: More Trials Are Needed to Guide Therapy

BACKGROUND: Currently, there are no published randomized controlled trials evaluating the efficacy and safety of adjunctive antiepileptic therapy in idiopathic generalized epilepsy with myoclonic seizures. METHODS: This randomized, double‐blind, placebo‐controlled multicenter trial assessed the efficacy and tolerability of adjunctive treatment with levetiracetam 3,000 mg/day in adolescents (12 years) and adults (65 years) with idiopathic generalized epilepsy, who experienced myoclonic seizures on 8 days during a prospective 8‐week baseline period, despite antiepileptic monotherapy. The 8‐week baseline period was followed by 4‐week up‐titration, 12‐week evaluation, and 6‐week down‐titration/conversion periods. RESULTS: Of 122 patients randomized, 120 (levetiracetam, n = 60; placebo, n = 60) were evaluable. Diagnoses were either juvenile myoclonic epilepsy (93.4%) or juvenile absence epilepsy (6.6%). A reduction of 50% in the number of days/week with myoclonic seizures was seen in 58.3% of patients in the levetiracetam group and in 23.3% of patients in the placebo group ( p < 0.001) during the treatment period. Levetiracetam‐treated patients were more likely to respond to treatment than patients receiving placebo (OR = 4.77; 95% CI, 2.12 to 10.77; p < 0.001). Levetiracetam‐treated patients had higher freedom from myoclonic seizures (25.0% vs 5.0%; p = 0.004) and all seizure types (21.7% vs 1.7%; p < 0.001) during the evaluation period. The only adverse events more frequent with levetiracetam were somnolence and neck pain. CONCLUSION: These results suggest that levetiracetam is an effective and well‐tolerated adjunctive treatment for patients with previously uncontrolled idiopathic generalized epilepsy with myoclonic seizures.