Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial.

Area of Science:

• Neurology
• Clinical Pharmacology

Background:

• Epilepsy affects millions globally, with partial-onset seizures being a common form.
• Many patients require adjunctive antiepileptic drugs (AEDs) to achieve seizure control.
• Uncontrolled seizures impact quality of life and increase risks.

Purpose of the Study:

• To assess the efficacy and safety of lacosamide as adjunctive therapy.
• Investigated lacosamide at 400 mg/day and 600 mg/day.
• Targeted patients with inadequately controlled partial-onset seizures on 1-3 other AEDs.

Main Methods:

• Multicenter, double-blind, placebo-controlled trial.
• Randomized 405 patients to placebo, lacosamide 400 mg/day, or lacosamide 600 mg/day (1:2:1 ratio).
• Included a baseline period, force-titration, and a 12-week maintenance phase.

Main Results:

• Lacosamide significantly reduced seizure frequency compared to placebo (ITT analysis).
• Median seizure reduction: 37.3% (400 mg) and 37.8% (600 mg) vs. 20.8% (placebo).
• Significant reductions in secondarily generalized tonic-clonic seizures observed, especially at 600 mg/day.

Conclusions:

• Adjunctive lacosamide (400 and 600 mg/day) is effective in reducing seizure frequency in partial-onset epilepsy.
• 400 mg/day offers a favorable efficacy/tolerability balance.
• 600 mg/day may provide additional benefits, particularly for generalized tonic-clonic seizures.