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

Phase 3

Recruiting

• Conditions: Epilepsy, Generalized
• Interventions: Drug: Cenobamate

• Registration Number: NCT06579573
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-12
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Gender and age: Japanese patients, regardless of gender, aged 18 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cenobamate	Cenobamate	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change in all generalized seizure frequency per 28-Day	12 Weeks of the Maintenance Phase	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.
Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval	12 Weeks of the Maintenance Phase	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

Trial Locations

Locations (25)

Aichi Medical University Hospital; 🇯🇵 Aichi, Japan

Hospital of the University of Occupational and Environmental Health, Japan; 🇯🇵 Fukuoka, Japan

Hokkaido University Hospital; 🇯🇵 Hokkaido, Japan

Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic; 🇯🇵 Fukushima, Japan

Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital; 🇯🇵 Hiroshima, Japan

Itami City Hospital; 🇯🇵 Hyōgo, Japan

Tsuchiura Kyodo General Hospita; 🇯🇵 Ibaraki, Japan

University of Tsukuba Hospital; 🇯🇵 Ibaraki, Japan

Kagoshima University Hospital; 🇯🇵 Kagoshima, Japan

SHOWA University Fujigaoka Hospital; 🇯🇵 Kanagawa, Japan

Yokohama City University Hospital; 🇯🇵 Kanagawa, Japan

National Hospital Organization Nishiniigata Chuo Hospital; 🇯🇵 Niigata, Japan

Koide Clinic of Epilepsy and Neurological Disorders; 🇯🇵 Osaka, Japan

NHO Shizuoka Institute of Epilepsy and Neurological Disorder; 🇯🇵 Shizuoka, Japan

TMG Asaka Medical Center; 🇯🇵 Saitama, Japan

Jichi Medical University Hospital; 🇯🇵 Tochigi, Japan

Jikei University Hospital; 🇯🇵 Tokyo, Japan

National Center of Neurology and Psychiatry; 🇯🇵 Tokyo, Japan

Maynds Tower Mental Clinic; 🇯🇵 Tokyo, Japan

Nihonbashi Neuro Clinic; 🇯🇵 Tokyo, Japan

Shinjuku Neuro Clinic; 🇯🇵 Tokyo, Japan

Tokyo Women's Medical University, Adachi Medical Center; 🇯🇵 Tokyo, Japan

Yamaguchi Grand Medical Center; 🇯🇵 Yamaguchi, Japan

University of Yamanashi Hospital; 🇯🇵 Yamanashi, Japan

Yamanashi Prefectural Central Hospital; 🇯🇵 Yamanashi, Japan