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.
Study ID
NCT07594158
Phase
PHASE3
Status
Recruiting
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Conditions

  • Partial Epilepsy

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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

Key Dates

Start date
May 30, 2026
Status verified
May 2026
Primary completion
Mar 30, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 2 to < 18 year olds

Primary Outcome Measure

Adverse events and adverse drug reactions [ Time Frame: 1 year ]

Central Contacts

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