Investigating ONO-2017 for Japanese patients with generalized tonic-clonic seizures

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

This study is testing a new medication called ONO-2017 to see if it can help Japanese adults with generalized tonic-clonic seizures when used alongside their current epilepsy treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Ono Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 25 sites (Aichi and 24 other locations)
• Trial ID: NCT06579573 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of ONO-2017 when used in conjunction with existing antiepileptic medications in Japanese patients diagnosed with primary generalized tonic-clonic seizures. Participants must be at least 18 years old and currently experiencing a minimum of five seizures within a 12-week period. The study will involve monitoring the effects of ONO-2017 on seizure frequency and overall patient safety. It is a Phase 3 interventional trial, indicating a focus on confirming the treatment's effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are Japanese adults aged 18 and older with a clinical diagnosis of primary generalized tonic-clonic seizures who are currently on 1 to 3 antiepileptic drugs.

Not a fit: Patients with a history of status epilepticus requiring hospitalization or those with non-epileptic seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of seizures in patients with generalized epilepsy.

How similar studies have performed: While this approach is being tested in this specific population, similar studies have shown promise in evaluating new antiepileptic drugs for seizure management.

Eligibility criteria

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.

Where this trial is running

Aichi and 24 other locations

• 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)

Study contacts

• Study coordinator: North America Clinical Trial Support Desk

Conditions Epilepsy, Generalized