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NCT Number: NCT06579573

ONO-2017 Study 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.

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Key information

Conditions

Epilepsy, Generalized Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Medical University Hospital, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.
  • Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
  • Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
  • Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens

Exclusion criteria

  • Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
  • Subject has seizure clusters where individual seizures cannot be counted orclassified.
  • History of non-epileptic or psychogenic seizures.
  • Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
  • 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.

Treatment and study plan

Cenobamate

Drug

Cenobamate will be orally administered once daily.

Primary outcomes

  1. Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval

    Time frame: 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 outcomes

  1. Percentage Change in all generalized seizure frequency per 28-Day

    Time frame: 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.

  2. Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2024
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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