Long-term daily CB03-154 treatment for focal epilepsy

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

This extension will try once-daily CB03-154 (up to 20 mg) in people with focal epilepsy who completed the prior Phase 2 study to see if it is safe, tolerated, and helps control seizures over up to two years.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Zhimeng Biopharma, Inc. (Industry-sponsored)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07238868 on ClinicalTrials.gov

What this trial studies

This open-label extension enrolls participants who successfully completed the randomized Phase 2 CB03-154-EP201 without early discontinuation to receive oral CB03-154 once daily at a maximum dose of 20 mg for up to two years. The study will track long-term safety, tolerability, seizure outcomes and drug levels (pharmacokinetics) on a scheduled visit and reporting plan, including seizure diaries. Only participants judged eligible by the investigator (no major protocol deviations or disqualifying adverse events in the parent study) may enter the extension. The sponsor is Shanghai Zhimeng Biopharma, and at least one site is located at Alfred Health in Melbourne, Australia.

Who should consider this trial

Good fit: Ideal candidates are people with focal epilepsy who completed the prior CB03-154-EP201 without early termination, can keep accurate seizure diaries, and can follow study visit requirements.

Not a fit: Patients who were withdrawn or met stopping criteria in the prior study, had important protocol deviations, serious adverse events, or have medical conditions that preclude long-term treatment are unlikely to benefit from joining this extension.

Why it matters

Potential benefit: If successful, long-term CB03-154 treatment could provide an additional daily oral option that reduces seizures and is well tolerated in people with focal epilepsy.

How similar studies have performed: CB03-154 is investigational with limited published data, though long-term open-label extension designs are commonly used and have supported safety and tolerability information for other antiseizure medications.

Eligibility criteria

Inclusion Criteria:

* 1\. 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.

  2\. 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).

  3\. 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.

  4\. Subject is able to keep accurate seizure diaries.

Exclusion Criteria:

\- 1. Subject met any of the withdrawal criteria while in Study CB03-154-EP201. 2. 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.

3\. 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.

Where this trial is running

Melbourne, Victoria

• Alfred Health — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Terence O'Brien, professor

Conditions Focal Epilepsy