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

NCT07594158 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Project Leader · Ono PharmaceuticalCo., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2028-03-30
Completion
2029-12-31
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07594158 on ClinicalTrials.gov