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

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

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.