A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds

NCT07594158 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ONO-2017-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Conditions

Partial Epilepsy

Outcome Measures

Primary Outcomes (1)

• Adverse events and adverse drug reactions

  1 year

Study Arms (1)

2 to < 18 year olds

EXPERIMENTAL

Drug: Cenobamate (tablet) for 12 to < 18 year olds; Drug: Cenobamate (syrup) for 2 to < 18 year olds

Interventions

Cenobamate (tablet) for 12 to < 18 year olds DRUG

The tablet form of ONO-2017 will be initiated at a dose of 12.5 mg once daily and titrated in the specified method to a target dose of 200 mg per day. The daily dose may be increased/reduced as appropriate according to symptoms within the range not exceeding 400 mg. In addition, depending on clinical response and tolerability, dose titration may be stopped at a dose of ≥ 50 mg per day to establish the maintenance dose. In principle, all doses should be taken with an appropriate amount of water in the morning. The dosage form for the doses will be selected by the principal investigator or designee. ONO-2017 can be treated until ONO-2017 is market approved, enters the market, and becomes available for supply to the study site.

2 to < 18 year olds

Cenobamate (syrup) for 2 to < 18 year olds DRUG

The syrup form of ONO-2017 will be administered at a dose equivalent to that for 12-18 year olds on a body weight basis

2 to < 18 year olds

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
• Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
• Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
• Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.

You may not qualify if:

• Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
• Patients with a history of non-epileptic psychogenic seizures.
• Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
• Patients diagnosed with Lennox-Gastaut syndrome.
• Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome \[DIHS\]) or drug-induced rash requiring hospitalization.

Sponsors & Collaborators

• Ono Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Japan Red Cross Fukuoka Hospital

Fukuoka, Japan

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Cenobamate; Tablets

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Project Leader

  Ono PharmaceuticalCo., Ltd.

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

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

International Clinical Trial Support Desk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)