Lacosamide (Adjunct for Partial) — 2007
(2007)Objective
Lacosamide - To evaluate the efficacy and safety of lacosamide as adjunctive therapy in patients with uncontrolled partial-onset seizures.
Study Summary
• Lacosamide demonstrated dose-dependent efficacy, with 400 mg/day showing optimal balance of benefit and tolerability.
Intervention
Lacosamide 200, 400, or 600 mg/day or placebo, given as adjunct to baseline AED regimen. Forced titration to target dose followed by 12-week maintenance.
Inclusion Criteria
Aged 16–70 years with partial-onset seizures for ≥2 years, ≥4 seizures during 8-week baseline, on stable 1–2 AEDs.
Study Design
Arms: Placebo vs Lacosamide 200 mg/day vs 400 mg/day vs 600 mg/day
Patients per Arm: Total: 485 patients (distributed roughly evenly across four groups)
Outcome
• Median seizure frequency reduction: 35.3% (400 mg) vs 20.0% (placebo), p < 0.01. • 600 mg/day group showed similar reduction (36.4%) without added benefit. • Responder rate: 40.5% (400 mg) vs 22.6% (placebo). • Adverse events increased with dose; most common were dizziness, nausea, and fatigue.