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RECRUITING
NCT07594158
PHASE3

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

Sponsor: Ono Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Official title: 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.

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-30

Completion Date

2029-12-31

Last Updated

2026-05-18

Healthy Volunteers

No

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

Locations (1)

Japan Red Cross Fukuoka Hospital

Fukuoka, Japan