A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of CB03-154 in Subjects Diagnosed with Epilepsy (NCT07238868)

This is a Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of CB03-154 in Subjects Diagnosed with Epilepsy. This study is an extension of a previous study called CB03-154-EP201. It aims to evaluate the long-term safety, tolerability, effectiveness and how the body processes the medication (known as pharmacokinetics or PK) of CB03-154 (known as the study drug) in the treatment of adult patients with epilepsy. Participants who successfully completed and did not terminate study treatment early from the CB03-154-EP201 study will be eligible for this study. This study has a treatment period of 104 weeks, and a down-titration (study drug dosage will be gradually reduced)/follow-up period of 8 weeks. The treatment duration will be up to 2 years. A data safety monitoring board (DSMB) will be established by the sponsor to review cumulative safety data at regular intervals throughout the study and monitor overall study conduct.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

Inclusion Criteria •The subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. •Subject must have successfully completed the DBP and have not terminated early from Study CB03-154-EP201, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study, and judged to be efficacious based on the blinded data review (in the opinion of the investigator). •In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements. •Subject is able to keep accurate seizure diaries. Exclusion Criteria •Subject met any of the withdrawal criteria while in Study CB03-154-EP201. •Subject has any medical condition, personal circumstance, or ongoing AE (from Study CB03-154-EP201) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol. •Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy during the study and until 28 days after completion of this study.