Long-term safety and seizure outcome in Japanese patients with Lennox-Gastaut syndrome receiving adjunctive rufinamide therapy: An open-label study following a randomized clinical trial

Epilepsy Research
Yoko OhtsukaKuniaki Iyoda

Abstract

To evaluate the long-term safety and seizure outcome in Japanese patients with Lennox-Gastaut syndrome (LGS) receiving adjunctive rufinamide therapy. We conducted an open-label extension study following a 12-week multicenter, randomized, double-blind, placebo-controlled study of adjunctive rufinamide therapy in Japanese patients with LGS. Fifty-four patients participated in the extension study. Seizure frequency was evaluated until 52 weeks after the start of the extension study. Adverse events (AEs) were evaluated throughout both studies. Of the 54 patients, 41 (75.9%) completed the extension study. The median duration of exposure to rufinamide was 818.0 days in all 54 patients, and 38 patients (70.4%) received rufinamide for 2 years or more. The median percent change in the frequency of tonic-atonic seizures relative to the frequency at the start of the double-blind study was -39.3% (12 weeks), -40.6% (24 weeks), -46.8% (32 weeks), -47.6% (40 weeks), and -36.1% (52 weeks). Reduction of total seizure frequency was also maintained until 52 weeks. Frequent treatment-related AEs were somnolence (20.4%), decreased appetite (16.7%), transient seizure aggravation including status epilepticus (13.0%), vomiting (11.1%), and constipati...Continue Reading

References

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Citations

Apr 25, 2018·The Cochrane Database of Systematic Reviews·Mariangela PanebiancoAnthony G Marson
Sep 1, 2018·Expert Opinion on Drug Safety·Romina MoaveroPaolo Curatolo
Feb 27, 2019·Current Neurology and Neuroscience Reports·Sean T HwangSimona V Proteasa
Nov 13, 2020·The Cochrane Database of Systematic Reviews·Mariangela PanebiancoAnthony G Marson
Nov 28, 2020·Epilepsy & Behavior : E&B·Debopam Samanta
Jan 23, 2021·CNS Drugs·Adam Strzelczyk, Susanne Schubert-Bast
Dec 27, 2019·Seizure : the Journal of the British Epilepsy Association·Arielle CrespelPierre Genton
Jun 14, 2021·Clinical Neurology and Neurosurgery·Fedor HlebokazovNatalia Goncharova
Jul 18, 2021·Seizure : the Journal of the British Epilepsy Association·Indar Kumar SharawatLesa Dawman
Oct 1, 2021·Developmental Medicine and Child Neurology·Lanlan ZhangChengzhong Wang

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