Lacosamide as adjunctive therapy for partial-onset seizures: A randomized controlled trial
Article first published online: 27 JAN 2010
Wiley Periodicals, Inc. © 2010 International League Against Epilepsy
Volume 51, Issue 6, pages 958–967, June 2010
How to Cite
Chung, S., Sperling, M. R., Biton, V., Krauss, G., Hebert, D., Rudd, G. D., Doty, P. and on behalf of the SP754 Study Group (2010), Lacosamide as adjunctive therapy for partial-onset seizures: A randomized controlled trial. Epilepsia, 51: 958–967. doi: 10.1111/j.1528-1167.2009.02496.x
- Issue published online: 1 JUN 2010
- Article first published online: 27 JAN 2010
- Accepted November 18, 2009; Early View publication January 27, 2010.
- Antiepileptic drugs;
- Partial-onset seizures;
- Randomized controlled trial;
Purpose: 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).
Methods: This multicenter, double-blind, placebo-controlled trial randomized patients 1:2:1 to placebo, lacosamide 400 mg, or lacosamide 600 mg/day. After an 8-week baseline period, patients began treatment with placebo or lacosamide 100 mg/day, were force-titrated weekly (100 mg/day increments) to the target dose, and entered a 12-week maintenance period.
Results: A total of 405 patients were randomized and received trial medication. Most (82.1%) were taking two to three concomitant AEDs. Median percent reductions in seizure frequency per 28 days from baseline to maintenance (intention-to-treat, ITT) were 37.3% for lacosamide 400 mg/day (p = 0.008) and 37.8% for lacosamide 600 mg/day (p = 0.006) compared to 20.8% for placebo, with responder rates of 38.3% and 41.2%, respectively, compared to placebo (18.3%, p < 0.001; ITT). Patients randomized to lacosamide showed large reductions in secondarily generalized tonic–clonic seizures, with median percent reductions in seizure frequency of 59.4% for lacosamide 400 mg/day and 93.0% for lacosamide 600 mg/day compared to 14.3% for placebo, and responder rates of 56.0% and 70.2% compared to placebo (33.3%). Dose-related adverse events included dizziness, nausea, and vomiting.
Discussion: Adjunctive treatment with lacosamide 400 and 600 mg/day reduced seizure frequency for patients with uncontrolled partial-onset seizures. Lacosamide 400 mg/day provided a good balance of efficacy and tolerability; lacosamide 600 mg/day may provide additional benefit for some patients as suggested by secondary efficacy analyses, including response in patients with secondarily generalized tonic–clonic seizures.