Long-Term Use of Oral Lacosamide in Young Children With Epilepsy Who Received Lacosamide in Previous Trials: Data From a Multicenter, Open-Label, Follow-Up Trial
Abstract number :
3.362
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2025
Submission ID :
71
Source :
www.aesnet.org
Presentation date :
12/8/2025 12:00:00 AM
Published date :
Authors :
Presenting Author: Carrie McClung, MS – UCB, Morrisville, NC, United States
Lien Heinzen, MS – UCB, Morrisville, NC, United States
Anne-Liv Schulz, MD – UCB
Paulette Williams, MS – UCB, Morrisville, NC, United States
Viktor Farkas, MD, PhD – Pediatric Center, Semmelweis University, Budapest, Hungary
Alla Kyrychenko, MD – Department of Internal Medicine, Dnipro Medical Institute of Conventional and Alternative Medicine, Dnipro, Ukraine
Iryna Makedonska, MD – Dnipro City Pediatric Clinical Hospital #6, Dnipro, Ukraine
Rationale: To assess the long-term use of lacosamide (LCM) oral solution in pediatric patients with epilepsy.
Methods: EP0151 (NCT04627285) was a phase 3, multicenter, long-term, open-label follow-up trial for pediatric patients < 6 years of age with epilepsy who had received LCM in a previous trial (EP0034 or SP848). This trial allowed patients to continue LCM treatment until they reached 6 years of age or until LCM oral solution was approved for patients < 4 years of age in the participating country (whichever was earliest). Situations where patients > 6 years of age required longer treatment with LCM oral solution (e.g., developmental delay, need for precise dosing) were assessed on a case-by-case basis following discussions between the investigator and the sponsor. In EP0151, investigators were allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction for each patient (minimum dose of 2 mg/kg/day; maximum dose of 12 mg/kg/day or 600 mg/day, whichever was lower). The maximum planned trial duration was ~213 weeks, including a ~205-week treatment period and up to 8-week end-of-study period (4-week taper and 30-day safety follow-up). Primary safety outcomes were treatment-emergent adverse events (TEAEs), discontinuations due to TEAEs, discontinuations due to serious adverse events (SAEs), modal daily dose, and maximum daily dose.
Results: Of 48 patients who received ≥ 1 LCM dose during the trial (Safety Set), 19 (39.6%) were ≥ 2 to < 4 years of age and 29 (60.4%) were ≥ 4 to < 6 years of age (median age at trial entry: 4.390 years; 68.8% male; Table 1). Most patients (68.8%) were taking 1–2 concomitant ASMs at the time of first dose of LCM in this trial. Patients were enrolled in 6 countries (Ukraine: 22 [45.8%], Hungary: 12 [25.0%], Romania: 6 [12.5%], Georgia: 5 [10.4%], Taiwan: 2 [4.2%], and Moldova: 1 [2.1%]). Overall, 37 patients (77.1%) completed the trial; primary reasons for discontinuation were adverse event (2 patients [4.2%]), patient withdrawal (2 patients [4.2%]), loss to follow-up (1 patient [2.1%]), and ‘other’ (6 patients [12.5%]). Five (10.4%), 5 (10.4%), 8 (16.7%), 22 (45.8%), and 8 (16.7%) patients completed < 12 months, 12 to < 24 months, 24 to < 36 months, 36 to < 48 months, and ≥ 48 months of treatment. Patients were exposed to LCM for a total of 128.474 patient-years (mean/median duration: 977.6/1093.0 days [range 1–1501 days]). Mean/median maximum LCM dose was 9.9/10.0 (range 3–12) mg/kg/day and mean/median modal LCM dose was 9.8/10.0 (range 3–12) mg/kg/day. Overall, 19 (39.6%) patients had TEAEs, most commonly upper respiratory tract infection (9 patients [18.8%]; Table 2). No TEAEs were considered drug-related by the investigator. Seven (14.6%) patients had serious TEAEs; no individual serious TEAE occurred in more than one patient. Two (4.2%) patients discontinued due to TEAEs/SAEs. These two patients died during the trial (due to acute cardiac failure and sudden death, respectively); neither death was considered related to LCM.
Conclusions: Long-term LCM treatment of children with epilepsy (< 6 years of age at trial entry) was well tolerated and no new safety signals were identified.
Funding: UCB-sponsored
Anti-seizure Medications