Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial
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, op...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-09-01
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| Series: | Epilepsia Open |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/epi4.12522 |
| _version_ | 1819018332963078144 |
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| author | Elinor Ben‐Menachem Jacqueline Dominguez József Szász Cynthia Beller Charles Howerton Lori Jensen Carrie McClung Robert Roebling Björn Steiniger‐Brach |
| author_facet | Elinor Ben‐Menachem Jacqueline Dominguez József Szász Cynthia Beller Charles Howerton Lori Jensen Carrie McClung Robert Roebling Björn Steiniger‐Brach |
| author_sort | Elinor Ben‐Menachem |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-21T03:17:45Z |
| format | Article |
| id | doaj.art-e81a1630b10d4915a70ef5863dd53e20 |
| institution | Directory Open Access Journal |
| issn | 2470-9239 |
| language | English |
| last_indexed | 2024-12-21T03:17:45Z |
| publishDate | 2021-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | Epilepsia Open |
| spelling | doaj.art-e81a1630b10d4915a70ef5863dd53e202022-12-21T19:17:47ZengWileyEpilepsia Open2470-92392021-09-016361862310.1002/epi4.12522Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trialElinor Ben‐Menachem0Jacqueline Dominguez1József Szász2Cynthia Beller3Charles Howerton4Lori Jensen5Carrie McClung6Robert Roebling7Björn Steiniger‐Brach8Institute for Clinical Neuroscience and Physiology, Sahlgrenska Academy University of Gothenburg Gothenburg SwedenInstitute for Neurosciences St. Luke’s Medical Center Quezon City PhilippinesGeorge Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureş Emergency Clinical County Hospital Targu Mures (Spitalul Clinic Judeţean de Urgenţă Târgu Mureş), Sectia Clinica Neurologie II Târgu Mureş RomaniaUCB Pharma Raleigh NC USAUCB Pharma Raleigh NC USAUCB Pharma Raleigh NC USAUCB Pharma Raleigh NC USAUCB Pharma Monheim am Rhein GermanyUCB Pharma Brussels BelgiumAbstract 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.https://doi.org/10.1002/epi4.12522epilepsylacosamidelong‐termmonotherapysafetytolerability |
| spellingShingle | Elinor Ben‐Menachem Jacqueline Dominguez József Szász Cynthia Beller Charles Howerton Lori Jensen Carrie McClung Robert Roebling Björn Steiniger‐Brach Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial Epilepsia Open epilepsy lacosamide long‐term monotherapy safety tolerability |
| title | Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial |
| title_full | Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial |
| title_fullStr | Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial |
| title_full_unstemmed | Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial |
| title_short | Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial |
| title_sort | long term safety and tolerability of lacosamide monotherapy in patients with epilepsy results from a multicenter open label trial |
| topic | epilepsy lacosamide long‐term monotherapy safety tolerability |
| url | https://doi.org/10.1002/epi4.12522 |
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