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

Yoko Ohtsuka, Harumi Yoshinaga, Yukiyoshi Shirasaka, Rumiko Takayama, Hiroki Takano, Kuniaki Iyoda

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Purpose: To evaluate the long-term safety and seizure outcome in Japanese patients with Lennox-Gastaut syndrome (LGS) receiving adjunctive rufinamide therapy. Subjects and methods: 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. Key findings: 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 constipation (11.1%). Adverse events were mild or moderate, except for transient seizure aggravation in three patients. Adverse events resulting in discontinuation of rufinamide were decreased appetite, drug eruption, and worsening of underlying autism. When clinically notable weight loss was defined as a decrease ≥7% relative to baseline, 22 patients (40.7%) experienced weight loss at least once during long-term observation, although weight loss was reported as an AE in only three patients. Significance: This study demonstrated a long-term benefit of rufinamide as adjunctive therapy for Japanese patients with LGS. Exacerbation of seizures and decreased appetite/weight loss should be monitored carefully.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalEpilepsy Research
Volume121
DOIs
Publication statusPublished - Mar 1 2016

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Seizures
Randomized Controlled Trials
Safety
Weight Loss
Appetite
Therapeutics
Lennox Gastaut Syndrome
rufinamide
Drug Eruptions
Status Epilepticus
Constipation
Autistic Disorder
Double-Blind Method
Vomiting
Placebos
Observation

Keywords

  • Lennox-Gastaut syndrome
  • Long-term administration
  • Rufinamide
  • Safety
  • Seizure outcome

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

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. / Ohtsuka, Yoko; Yoshinaga, Harumi; Shirasaka, Yukiyoshi; Takayama, Rumiko; Takano, Hiroki; Iyoda, Kuniaki.

In: Epilepsy Research, Vol. 121, 01.03.2016, p. 1-7.

Research output: Contribution to journalArticle

Ohtsuka, Yoko ; Yoshinaga, Harumi ; Shirasaka, Yukiyoshi ; Takayama, Rumiko ; Takano, Hiroki ; Iyoda, Kuniaki. / 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. In: Epilepsy Research. 2016 ; Vol. 121. pp. 1-7.
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