ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Last updated: August 28, 2024
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Seizure Disorders

Treatment

Cenobamate

Clinical Study ID

NCT06579573
ONO-2017-01
  • Ages > 18
  • All Genders

Study Summary

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Gender and age: Japanese patients, regardless of gender, aged 18 years or older atthe time of informed consent.

  2. Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizuresin the setting of idiopathic generalized epilepsy.

  3. Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.

  4. Subject is currently receiving 1 to a maximum of 3 concomitant AntiepilepticDrugs(AEDs) with fixed dosing regimens

Exclusion

Exclusion Criteria:

  1. Subject has a history of status epilepticus that required hospitalization within 15months prior to enrollment.

  2. Subject has seizure clusters where individual seizures cannot be countedorclassified.

  3. History of non-epileptic or psychogenic seizures.

  4. Subject has a concomitant diagnosis of Partial Onset Seizure(POS).

  5. Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis,drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-inducedhypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Cenobamate
Phase: 3
Study Start date:
July 12, 2022
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Aichi Medical University Hospital

    Aichi,
    Japan

    Active - Recruiting

  • Hospital of the University of Occupational and Environmental Health, Japan

    Fukuoka,
    Japan

    Active - Recruiting

  • Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic

    Fukushima,
    Japan

    Active - Recruiting

  • Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital

    Hiroshima,
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Hokkaido,
    Japan

    Active - Recruiting

  • Itami City Hospital

    Hyōgo,
    Japan

    Active - Recruiting

  • Tsuchiura Kyodo General Hospita

    Ibaraki,
    Japan

    Active - Recruiting

  • University of Tsukuba Hospital

    Ibaraki,
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima,
    Japan

    Active - Recruiting

  • SHOWA University Fujigaoka Hospital

    Kanagawa,
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Kanagawa,
    Japan

    Active - Recruiting

  • National Hospital Organization Nishiniigata Chuo Hospital

    Niigata,
    Japan

    Active - Recruiting

  • Koide Clinic of Epilepsy and Neurological Disorders

    Osaka,
    Japan

    Active - Recruiting

  • TMG Asaka Medical Center

    Saitama,
    Japan

    Active - Recruiting

  • NHO Shizuoka Institute of Epilepsy and Neurological Disorder

    Shizuoka,
    Japan

    Active - Recruiting

  • Jichi Medical University Hospital

    Tochigi,
    Japan

    Active - Recruiting

  • Jikei University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Maynds Tower Mental Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • National Center of Neurology and Psychiatry

    Tokyo,
    Japan

    Active - Recruiting

  • Nihonbashi Neuro Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Shinjuku Neuro Clinic

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University, Adachi Medical Center

    Tokyo,
    Japan

    Active - Recruiting

  • Yamaguchi Grand Medical Center

    Yamaguchi,
    Japan

    Active - Recruiting

  • University of Yamanashi Hospital

    Yamanashi,
    Japan

    Active - Recruiting

  • Yamanashi Prefectural Central Hospital

    Yamanashi,
    Japan

    Active - Recruiting

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