VALOR
(2020)Objective
Lacosamide - To evaluate the efficacy and safety of adjunctive lacosamide in patients ≥4 years old with idiopathic generalized epilepsy and primary generalized tonic-clonic seizures (PGTCS).
Study Summary
• Lacosamide significantly delayed time to second PGTCS and improved seizure outcomes compared to placebo.
Intervention
Adjunctive oral lacosamide (up to 400 mg/day or 12 mg/kg/day) vs placebo added to stable background AEDs.
Inclusion Criteria
Patients ≥4 years old with idiopathic generalized epilepsy and ≥3 PGTCS in the 16-week baseline (with at least 2 historical and 1 prospective event).
Study Design
Arms: Lacosamide vs Placebo
Patients per Arm: Lacosamide: 121; Placebo: 121
Outcome
• Time to second PGTCS: HR 0.540 (95% CI 0.377–0.774, p<0.001); 55.3% (lacosamide) vs 33.4% (placebo) remained seizure-free. • 24-week PGTCS freedom: 31.3% vs 17.2% (difference 14.1%, p=0.011). • ≥50% seizure reduction: 68.1% (lacosamide), 46.3% (placebo). • ≥75% seizure reduction: 57.1% vs 36.4%. • Observed seizure freedom: 27.5% vs 13.2%. • TEAEs: 79.3% (lacosamide) vs 65.3% (placebo); common events included dizziness, somnolence, headache. • Serious TEAEs: 6.6% (lacosamide) vs 3.3% (placebo); no deaths.