An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset SEizures: PORTABLE Study (interim report at 12 Months)

DOI
  • Akamatsu Naoki
    Department of Neurology, International University of Health and Welfare School of Medicine
  • Nakamoto Hidetoshi
    Department of Neurosurgery, Medical Corporation Musashino-kai TMG Asaka Medical Center
  • Ochiai Taku
    Department of Neurosurgery, Medical Corporation Brain Concierge Ochiai Brain Clinic
  • Kubota Yuichi
    Department of Neurosurgery, Tokyo Women's Medical University, Adachi Medical Center
  • Ninomiya Hirotomo
    Department of Neurosurgery, Itami City Hospital
  • Hanaya Ryosuke
    Department of Neurosurgery, Kagoshima University Hospital
  • Watanabe Masako
    Department of Psychiatry, Medical Corporation Senshi-kai Shinjuku Neuro Clinic
  • Koide Yasumichi
    Department of Neurology, Koide Clinic of Epilepsy and Neurological Disorders
  • Wakita Yusuke
    North Tohoku Epilepsy Center, Medical Corporation Seishou-kai Minato Hospital
  • Kaneko Sunao
    North Tohoku Epilepsy Center, Medical Corporation Seishou-kai Minato Hospital
  • Kanemura Hideaki
    Department of Pediatrics, Toho University Medical Center Sakura Hospital
  • Ono Tomonori
    Department of Neurosurgery, National Hospital Organization Nagasaki Medical Center
  • Hagiwara Koichi
    Epilepsy and Sleep Center, Medical Corporation Koho-kai Fukuoka Sanno Hospital
  • Uehara Taira
    Epilepsy and Sleep Center, Medical Corporation Koho-kai Fukuoka Sanno Hospital
  • Maehara Taketoshi
    Department of Neurosurgery, Institute of Science Tokyo Hospital
  • Motooka Hiromichi
    Department of Psychiatry and Neurology, Kurume University Hospital
  • Terada Kiyohito
    Department of Neurology and Psychiatry, Yokohama Minoru Epilepsy & Developmental Clinic
  • Nishimoto Shohei
    Medical Affairs Unit, Eisai Co.
  • Tanaka Karin
    Medical Affairs Unit, Eisai Co.
  • Tsuruda Taisei
    Medical Affairs Unit, Eisai Co.

Bibliographic Information

Other Title
  • てんかん患者におけるペランパネル一次単剤療法に関する観察研究（PORTABLE Study）の12カ月時中間報告

Description

<p>Perampanel (PER) is a novel class of anti-seizure medication and selective, non-competitive inhibitor of the α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor. We investigated the efficacy and safety of PER as a first-line monotherapy over a long period of time (30 months), as well as its impact on QOL, and will provide an interim report at 12 months. We studied 61 patients aged 4 years and older who were diagnosed with new-onset or recurrent epilepsy with focal-onset seizures and started treatment with PER alone. The dose of PER in actual clinical practice at 12 months of treatment may be low, suggesting that initiation and maintenance of a low dose may be effective in reducing neurological side effects, especially. The results suggest that the efficacy, retention rate and safety of PER are similar to those reported at the time of clinical trials and in clinical practice in other countries. Furthermore, no deterioration in the QOL of patients or their guardians was observed. These findings highlight the importance of PER as a clinical treatment option for newly diagnosed patients with epilepsy, including children and older adults.</p>

Journal

Keywords

Details 詳細情報について

  • CRID
    1390866117160452224
  • DOI
    10.3805/jjes.42.635
  • ISSN
    13475509
    09120890
  • Text Lang
    ja
  • Data Source
    • JaLC
  • Abstract License Flag
    Disallowed

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