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

A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.

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

Study Overview

• Status: Recruiting
• Conditions: Partial Epilepsy
• Intervention / Treatment: Drug: Cenobamate (tablet) for 12 to < 18 year olds; Drug: Cenobamate (syrup) for 2 to < 18 year olds

Detailed Description

Secondary objectives:

To evaluate the efficacy of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset (focal) seizures

To evaluate the pharmacokinetics of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset seizures

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: North America Clinical Trial Support Desk; Phone Number: +18665877745 (Toll-Free); Email: clinical_trial@ono-pharma.com
• Study Contact Backup: Name: International Clinical Trial Support Desk; Phone Number: +17162141777 (Standard); Email: clinical_trial@ono-pharma.com

Study Locations

• Japan
  • Fukuoka, Japan
    • Recruiting
    • Japan Red Cross Fukuoka Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 2 to < 18 year olds

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events and adverse drug reactions	1 year

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co., Ltd.
• Investigators: Study Director: Project Leader, Ono PharmaceuticalCo., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial; Pharmaceutical Preparations; Dosage Forms; Cenobamate; Tablets
• Other Study ID Numbers: ONO-2017-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes