Actively Recruiting

Phase 3
Age: 12Years +
All Genders
NCT06579573

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

Led by Ono Pharmaceutical Co., Ltd. · Updated on 2025-06-17

15

Participants Needed

25

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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
Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Aichi Medical University Hospital

Aichi, Japan

Actively Recruiting

2

Hospital of the University of Occupational and Environmental Health, Japan

Fukuoka, Japan

Actively Recruiting

3

Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic

Fukushima, Japan

Actively Recruiting

4

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

Hiroshima, Japan

Actively Recruiting

5

Hokkaido University Hospital

Hokkaido, Japan

Actively Recruiting

6

Itami City Hospital

Hyōgo, Japan

Actively Recruiting

7

Tsuchiura Kyodo General Hospita

Ibaraki, Japan

Actively Recruiting

8

University of Tsukuba Hospital

Ibaraki, Japan

Actively Recruiting

9

Kagoshima University Hospital

Kagoshima, Japan

Actively Recruiting

10

SHOWA University Fujigaoka Hospital

Kanagawa, Japan

Actively Recruiting

11

Yokohama City University Hospital

Kanagawa, Japan

Actively Recruiting

12

National Hospital Organization Nishiniigata Chuo Hospital

Niigata, Japan

Actively Recruiting

13

Koide Clinic of Epilepsy and Neurological Disorders

Osaka, Japan

Actively Recruiting

14

TMG Asaka Medical Center

Saitama, Japan

Actively Recruiting

15

NHO Shizuoka Institute of Epilepsy and Neurological Disorder

Shizuoka, Japan

Actively Recruiting

16

Jichi Medical University Hospital

Tochigi, Japan

Actively Recruiting

17

Jikei University Hospital

Tokyo, Japan

Actively Recruiting

18

Maynds Tower Mental Clinic

Tokyo, Japan

Actively Recruiting

19

National Center of Neurology and Psychiatry

Tokyo, Japan

Actively Recruiting

20

Nihonbashi Neuro Clinic

Tokyo, Japan

Actively Recruiting

21

Shinjuku Neuro Clinic

Tokyo, Japan

Actively Recruiting

22

Tokyo Women's Medical University, Adachi Medical Center

Tokyo, Japan

Actively Recruiting

23

Yamaguchi Grand Medical Center

Yamaguchi, Japan

Actively Recruiting

24

University of Yamanashi Hospital

Yamanashi, Japan

Actively Recruiting

25

Yamanashi Prefectural Central Hospital

Yamanashi, Japan

Actively Recruiting

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Research Team

N

North America Clinical Trial Support Desk

CONTACT

I

International Clinical Trial Support Desk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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