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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: North America Clinical Trial Support Desk
• Email: clinical_trial@ono-pharma.com
• Phone: +18665877745(Toll-Free)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

  This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07680842

• Natural history assessment of Baker Gordon Syndrome

  This study is trying to learn more about how Baker Gordon Syndrome affects people over time by tracking their symptoms and collecting important health information to help with future treatments.

  Recruiting University of Missouri-Columbia · Columbia, Missouri · NCT06399952

• Understanding idiopathic generalized epilepsy syndromes

  This study looks at different types of idiopathic generalized epilepsy to see how they affect patients and what treatments might work best for them.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT06388174

• Using electrical stimulation on the scalp to treat epilepsy

  This study is testing if a type of electrical stimulation on the scalp can help people with different kinds of epilepsy have fewer and less severe seizures.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT05673915

• Evaluating PRAX-628 for treating focal onset and tonic-clonic seizures in adults

  This study is testing a new medication called PRAX-628 to see if it can help adults with focal onset or tonic-clonic seizures better control their symptoms while they are already on other seizure medications.

  Recruiting at 11 sites Phase 2 Praxis Precision Medicines · Phoenix, Arizona and 10 other locations · NCT06908356

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.