臨床研究等提出・公開システム

Date of registration	May. 12, 2026
Last modified on	May. 12, 2026
Trial ID	jRCT2071260025

Scientific Title	ONO-2017-04: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.
Public Title	A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 year olds

Contact for Scientific Queries	Name	Hirashima Yoshinori
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	JP Clinical Trial Support Desk
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 30, 2026
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	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
	Age Minimum	2age old over
	Age Maximum	18age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Partial onset seizures in epilepsy patients (including secondarily generalized seizures)
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.
Primary Outcome(s)		Adverse events and adverse drug reaction
Secondary Outcome(s)		Percentage change from the pre-observation period in seizure frequency per 28 days during the treatment period and in each phase

Primary Sponsor	Ono Pharmaceutical Co.,LTD.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Japan Red Cross Fukuoka Hospital IRB
Address	Ogusu 3-1-1, Minami-ku fukuoka-shi, Fukuoka, Fukuoka
Telephone	+81-570-03-1211
E-Mail	fukuoka-kenkyu@fukuoka-med.jrc.or.jp
Approval Status	Approval
Date of approval	Mar. 12, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none