Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial

The primary objective of this trial (SP1042; NCT02582866) was to assess long‐term safety and tolerability of lacosamide monotherapy (200‐600 mg/day) in adults with focal (partial‐onset) seizures or generalized tonic‐clonic seizures (without clear focal origin). This Phase III, long‐term, open‐label, multicenter, follow‐up trial enrolled patients with epilepsy who were taking lacosamide in, and completed, the previous double‐blind trial (SP0994; NCT01465997). Primary safety outcomes were treatment‐emergent adverse events (TEAEs), discontinuations due to TEAEs, and serious TEAEs. One hundred and six patients were enrolled and received lacosamide: 84 (79.2%) completed the trial and 22 (20.8%) discontinued. The median duration of exposure was 854.0 days, with a median modal dose of 200 mg/day. Ninety‐six (90.6%), 64 (60.4%), and 44 (41.5%) patients had ≥12, ≥24, and ≥36 months of lacosamide exposure, respectively. At least one TEAE was reported by 61 (57.5%) patients. The most common (≥4%) TEAEs were headache (10 [9.4%]), nasopharyngitis (eight [7.5%]), and back pain (five [4.7%]). One (0.9%) patient discontinued due to a TEAE (sudden unexpected death in epilepsy; not considered drug‐related), 14 (13.2%) patients reported serious TEAEs, and seven (6.6%) patients reported TEAEs that were considered drug‐related. Overall, long‐term lacosamide monotherapy was generally well tolerated up to 600 mg/day, with no new safety signals identified.