臨床研究等提出・公開システム

Scientific Title	ONO-2017-02:A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects with Partial Onset Seizures
Public Title	ONO-2017-02:An Open-Label Extension study of Cenobamate in Japanese Subjects with Partial Onset Seizures

Contact for Scientific Queries	Name	Osawa Masahiro
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120626190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Center Information Medical
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120626190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 04, 2022
Actual date of first enrollment		Nov. 04, 2022
Target sample size		100
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	Subjects completed Study YKP3089C035 by SK Life Science.
	Exclusion Criteria	1.Subjects that have previously discontinued for any reason from the Core study (YKP3089C035). 2.Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Partial Onset Seizures with epilepsy
Intervention(s)		Subjects will start initial dose as same as the lastdose from YKP3089C035 study. Doses may be decreased or subsequently increased in 50 mg/day decrements or increments, with the minimum and maximum dose range of 50 mg/day -400 mg/day.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety and tolerability
Secondary Outcome(s)		Efficacy (seizure frequency)

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hayashi Diabetes Clinic Institutional Review Board
Address	Abeasa Medical 2F, 3-2 Shineicho, Chigasaki City, Kanagawa
Telephone	+81-42-648-5551
E-Mail	htonyou-irb@eps.co.jp
Approval Status	Approval
Date of approval	Aug. 17, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06590896
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history