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

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

Recruiting
12 years and older
All
Phase 3

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Overview

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

Eligibility

Inclusion Criteria:

  1. Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.
  2. Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in 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 Antiepileptic Drugs(AEDs) with fixed dosing regimens

Exclusion Criteria:

  1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
  2. Subject has seizure clusters where individual seizures cannot be counted orclassified.
  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-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.

Study details
    Epilepsy
    Generalized

NCT06579573

Ono Pharmaceutical Co. Ltd

16 October 2025

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