ONO-2017-02:An Open-Label Extension study of Cenobamate in Japanese Subjects with Partial Onset Seizures

JRCT ID: jRCT2031220198

Registered date:08/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Partial Onset Seizures with epilepsy
• Date of first enrollment: 04/11/2022
• Target sample size: 100
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Safety and tolerability
• Secondary Outcome: Efficacy (seizure frequency)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Subjects completed Study YKP3089C035 by SK Life Science.

Exclude 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.

Related Information

• Primary Sponsor: Osawa Masahiro