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Recruiting Phase 3

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

NCT06579573 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2022-07-12
Last updated
2025-06-17

Condition(s) studied

Epilepsy, Generalized

Investigational drug(s) / intervention(s)

Cenobamate →

Cenobamate: Cenobamate will be orally administered once daily.

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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval — 12 Weeks of the Maintenance Phase
    Convert the frequency of generalized tonic-clonic seizures (PGTC) in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.

Trial sites (25)

FacilityCityRegionStatus
Aichi Medical University Hospital Aichi Japan Recruiting
Hospital of the University of Occupational and Environmental Health, Japan Fukuoka Japan Recruiting
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic Fukushima Japan Recruiting
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan Recruiting
Hokkaido University Hospital Hokkaido Japan Recruiting
Itami City Hospital Hyōgo Japan Recruiting
Tsuchiura Kyodo General Hospita Ibaraki Japan Recruiting
University of Tsukuba Hospital Ibaraki Japan Recruiting
Kagoshima University Hospital Kagoshima Japan Recruiting
SHOWA University Fujigaoka Hospital Kanagawa Japan Recruiting
Yokohama City University Hospital Kanagawa Japan Recruiting
National Hospital Organization Nishiniigata Chuo Hospital Niigata Japan Recruiting
Koide Clinic of Epilepsy and Neurological Disorders Osaka Japan Recruiting
TMG Asaka Medical Center Saitama Japan Recruiting
NHO Shizuoka Institute of Epilepsy and Neurological Disorder Shizuoka Japan Recruiting
Jichi Medical University Hospital Tochigi Japan Recruiting
Jikei University Hospital Tokyo Japan Recruiting
Maynds Tower Mental Clinic Tokyo Japan Recruiting
National Center of Neurology and Psychiatry Tokyo Japan Recruiting
Nihonbashi Neuro Clinic Tokyo Japan Recruiting
Shinjuku Neuro Clinic Tokyo Japan Recruiting
Tokyo Women's Medical University, Adachi Medical Center Tokyo Japan Recruiting
Yamaguchi Grand Medical Center Yamaguchi Japan Recruiting
University of Yamanashi Hospital Yamanashi Japan Recruiting
Yamanashi Prefectural Central Hospital Yamanashi Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06579573 on ClinicalTrials.gov ↗ ← All trials in Japan