Lacosamide (Adjunct for Partial)
(2010)Objective
Lacosamide - To evaluate the efficacy and safety of lacosamide (400 and 600 mg/day) as adjunctive treatment in patients with uncontrolled partial-onset seizures taking one to three concomitant antiepileptic drugs (AEDs).
Study Summary
• Lacosamide significantly reduced seizure frequency and improved responder rates compared to placebo.
Intervention
Adjunctive lacosamide at doses of 400 mg/day and 600 mg/day, compared to placebo, with forced weekly titration.
Inclusion Criteria
Adults with uncontrolled partial-onset seizures on 1–3 concomitant AEDs, following an 8-week baseline period.
Study Design
Arms: Placebo vs Lacosamide 400 mg/day vs Lacosamide 600 mg/day
Patients per Arm: Placebo: ~101; Lacosamide 400 mg: ~203; Lacosamide 600 mg: ~101
Outcome
• Median seizure frequency reduction: 37.3% (400 mg), 37.8% (600 mg) vs 20.8% (placebo). • Responder rates (≥50% reduction): 38.3% (400 mg), 41.2% (600 mg) vs 18.3% (placebo); p < 0.001. • Reduction in secondarily generalized tonic–clonic seizures: 59.4% (400 mg), 93.0% (600 mg) vs 14.3% (placebo). • Adverse events were dose-related, including dizziness, nausea, and vomiting.