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

ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy, Generalized
• Intervention / Treatment: Drug: Cenobamate

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: North America Clinical Trial Support Desk; Phone Number: +18665877745(Toll-Free); Email: clinical_trial@ono-pharma.com
• Study Contact Backup: Name: International Clinical Trial Support Desk; Phone Number: +17162141777(Standard); Email: clinical_trial@ono-pharma.com

Study Locations

• Japan
  • Aichi, Japan
    • Recruiting
    • Aichi Medical University Hospital
  • Fukuoka, Japan
    • Recruiting
    • Hospital of the University of Occupational and Environmental Health, Japan
  • Fukushima, Japan
    • Recruiting
    • Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
  • Hiroshima, Japan
    • Recruiting
    • Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
  • Hokkaido, Japan
    • Recruiting
    • Hokkaido University Hospital
  • Hyōgo, Japan
    • Recruiting
    • Itami City Hospital
  • Ibaraki, Japan
    • Recruiting
    • University of Tsukuba Hospital
  • Ibaraki, Japan
    • Recruiting
    • Tsuchiura Kyodo General Hospita
  • Kagoshima, Japan
    • Recruiting
    • Kagoshima University Hospital
  • Kanagawa, Japan
    • Recruiting
    • Showa University Fujigaoka Hospital
  • Kanagawa, Japan
    • Recruiting
    • Yokohama City University Hospital
  • Niigata, Japan
    • Recruiting
    • National Hospital Organization Nishiniigata Chuo Hospital
  • Osaka, Japan
    • Recruiting
    • Koide Clinic of Epilepsy and Neurological Disorders
  • Saitama, Japan
    • Recruiting
    • TMG Asaka Medical Center
  • Shizuoka, Japan
    • Recruiting
    • NHO Shizuoka Institute of Epilepsy and Neurological Disorder
  • Tochigi, Japan
    • Recruiting
    • Jichi Medical University Hospital
  • Tokyo, 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
  • Yamaguchi, Japan
    • Recruiting
    • Yamaguchi Grand Medical Center
  • Yamanashi, Japan
    • Recruiting
    • University of Yamanashi Hospital
  • Yamanashi, Japan
    • Recruiting
    • Yamanashi Prefectural Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cenobamate	Drug: Cenobamate; Cenobamate will be orally administered once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval	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.	12 Weeks of the Maintenance Phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in all generalized seizure frequency per 28-Day	Convert the frequency of all generalized seizures in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.	12 Weeks of the Maintenance Phase
Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval	The percentage of subjects who have a 50%, 75%, 90%, and 100% reduction in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to the Pre-treatment Phase	12 Weeks of the Maintenance Phase

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 15, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Seizures; Epilepsy, Generalized; Anticonvulsants; Cenobamate
• Other Study ID Numbers: ONO-2017-01; jRCT2031210624 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No