Wendy Waldman Zadeh1, Antonio Escartin2, William Byrnes3, Frank Tennigkeit4, Simon Borghs5, Ting Li6, Peter Dedeken7, Marc De Backer8. 1. Broadlawns Medical Center, 1801 Hickman Road, Des Moines, IA 50314, USA. Electronic address: wwaldman@broadlawns.org. 2. Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Avda. Sant Antoni Maria Claret 167, 08025 Barcelona, Spain. Electronic address: aescartin@santpau.cat. 3. UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Bill.Byrnes@ucb.com. 4. UCB Pharma, Alfred-Nobel-Straße 10, 40789 Monheim am Rhein, Germany. Electronic address: Frank.Tennigkeit@ucb.com. 5. UCB Pharma, 208 Bath Road, Slough SL1 3WE, UK. Electronic address: simon.borghs@ucb.com. 6. UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Ting.Li@ucb.com. 7. UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: Peter.Dedeken@ucb.com. 8. UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: Marc.DeBacker@ucb.com.
Abstract
PURPOSE: To evaluate the efficacy and safety of lacosamide administered as either first add-on or later add-on antiepileptic drug (AED) therapy for patients with uncontrolled partial-onset seizures (POS). METHODS: In this open-label, multicentre trial, patients with POS initiated oral lacosamide (titrated to 400 mg/day) either as add-on to first AED monotherapy, or as later add-on to 1-3 concomitant AEDs after ≥ 2 previous AEDs. The primary efficacy variable was the proportion of patients achieving seizure freedom for the first 12 weeks of the 24-week Maintenance Phase. RESULTS: 456 patients received ≥ 1 dose of lacosamide (96 as first add-on, 360 as later add-on). In the first add-on cohort, 27/72 (37.5%) patients completed 12 weeks treatment and remained seizure-free; 18/68 (26.5%) remained seizure-free after 24 weeks. 64/91 (70.3%) patients achieved ≥ 50% reduction in seizure frequency during maintenance treatment. This was accompanied by a mean 7.1 ± 16.00 point improvement from Baseline in the Quality of Life Inventory in Epilepsy (QOLIE-31-P) total score for 24-week completers, with improvement reported in all subscales. Most common treatment-emergent adverse events (TEAEs) were dizziness (31.3%) and headache (13.5%). In the later add-on cohort, 39/261 (14.9%) and 29/249 (11.6%) patients remained seizure-free after completing 12 and 24 weeks' treatment, respectively. 178/353 (50.4%) patients achieved ≥ 50% reduction in seizure frequency during maintenance treatment. Mean change in QOLIE-31-P total score was 4.8 ± 14.74 points among 24-week completers. Common TEAEs were dizziness (33.6%), somnolence (15.0%) and headache (11.4%). CONCLUSIONS: Lacosamide initiated as first add-on treatment was efficacious and well tolerated in patients with uncontrolled POS.
PURPOSE: To evaluate the efficacy and safety of lacosamide administered as either first add-on or later add-on antiepileptic drug (AED) therapy for patients with uncontrolled partial-onset seizures (POS). METHODS: In this open-label, multicentre trial, patients with POS initiated oral lacosamide (titrated to 400 mg/day) either as add-on to first AED monotherapy, or as later add-on to 1-3 concomitant AEDs after ≥ 2 previous AEDs. The primary efficacy variable was the proportion of patients achieving seizure freedom for the first 12 weeks of the 24-week Maintenance Phase. RESULTS: 456 patients received ≥ 1 dose of lacosamide (96 as first add-on, 360 as later add-on). In the first add-on cohort, 27/72 (37.5%) patients completed 12 weeks treatment and remained seizure-free; 18/68 (26.5%) remained seizure-free after 24 weeks. 64/91 (70.3%) patients achieved ≥ 50% reduction in seizure frequency during maintenance treatment. This was accompanied by a mean 7.1 ± 16.00 point improvement from Baseline in the Quality of Life Inventory in Epilepsy (QOLIE-31-P) total score for 24-week completers, with improvement reported in all subscales. Most common treatment-emergent adverse events (TEAEs) were dizziness (31.3%) and headache (13.5%). In the later add-on cohort, 39/261 (14.9%) and 29/249 (11.6%) patients remained seizure-free after completing 12 and 24 weeks' treatment, respectively. 178/353 (50.4%) patients achieved ≥ 50% reduction in seizure frequency during maintenance treatment. Mean change in QOLIE-31-P total score was 4.8 ± 14.74 points among 24-week completers. Common TEAEs were dizziness (33.6%), somnolence (15.0%) and headache (11.4%). CONCLUSIONS:Lacosamide initiated as first add-on treatment was efficacious and well tolerated in patients with uncontrolled POS.
Authors: Roberta Rudà; Caroline Houillier; Marta Maschio; Jaap C Reijneveld; Scarlett Hellot; Marc De Backer; Jane Chan; Lars Joeres; Iryna Leunikava; Martin Glas; Robin Grant Journal: Epilepsia Date: 2020-04 Impact factor: 5.864
Authors: Elizabeth Thiele; Eric Marsh; Maria Mazurkiewicz-Beldzinska; Jonathan J Halford; Boudewijn Gunning; Orrin Devinsky; Daniel Checketts; Claire Roberts Journal: Epilepsia Date: 2019-02-11 Impact factor: 5.864
Authors: Elinor Ben-Menachem; Hans Peter Grebe; Kiyohito Terada; Lori Jensen; Ting Li; Marc De Backer; Björn Steiniger-Brach; Teresa Gasalla; Melissa Brock; Victor Biton Journal: Epilepsia Date: 2019-11-21 Impact factor: 5.864