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

Elinor Ben-Menachem, Jacqueline Dominguez, József Szász, Cynthia Beller, Charles Howerton, Lori Jensen, Carrie McClung, Robert Roebling, Björn Steiniger-Brach, Elinor Ben-Menachem, Jacqueline Dominguez, József Szász, Cynthia Beller, Charles Howerton, Lori Jensen, Carrie McClung, Robert Roebling, Björn Steiniger-Brach

Abstract

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.

Keywords: epilepsy; lacosamide; long-term; monotherapy; safety; tolerability.

Conflict of interest statement

Elinor Ben‐Menachem has served as a paid consultant for Arvelle Therapeutics, GW Pharmaceuticals, and UCB Pharma. Jacqueline Dominguez received honorarium as a speaker for Hi‐Eisai Pharmaceutical and A. Menarini Philippines. József Szász has received speaking honoraria from and served as a paid consultant for AbbVie, Boehringer Ingelheim, GlaxoSmithKline, Lundbeck, Novartis, Pfizer, Teva, and UCB Pharma. Cynthia Beller, Charles Howerton, Lori Jensen, Carrie McClung, Robert Roebling, and Björn Steiniger‐Brach are employees of UCB Pharma. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.

© 2021 The Authors. Epilepsia Open published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.

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Source: PubMed

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