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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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Partial onset seizures in epilepsy patients (including secondarily generalized seizures)
Date of first enrollment	30/05/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	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 or reduced as appropriate according to symptoms within the range not exceeding 400 mg.

Outcome(s)

Primary Outcome	Adverse events and adverse drug reaction
Secondary Outcome	Percentage change from the pre-observation period in seizure frequency per 28 days during the treatment period and in each phase

Key inclusion & exclusion criteria

Age minimum	>= 2age old
Age maximum	< 18age old
Gender	Both
Include criteria	- Japanese male or female patients aged 2 to under 18 years at the time ofinformed consent. - Patients diagnosed with epilepsy as having POS with uncontrolled seizuresat least 6 months prior to informed consent, regardless of the presence orabsence 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 forat least 2 months before registration
Exclude 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