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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06579573

Enrollment

Registered

2024-08-30

Start date

2022-07-12

Completion date

2027-01-31

Last updated

2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Generalized

Brief summary

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

Interventions

DRUGCenobamate

Cenobamate will be orally administered once daily.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Japan

Contacts

Primary ContactNorth America Clinical Trial Support Desk

clinical_trial@ono-pharma.com+18665877745(Toll-Free)

Backup ContactInternational Clinical Trial Support Desk

clinical_trial@ono-pharma.com+17162141777(Standard)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026