An Open-label Study to Evaluate Safety, Tolerability, and Efficacy of CB03-154 in Subjects Diagnosed With Epilepsy

NCT ID: NCT07238868

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2029-06-30

Brief Summary

CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.

Detailed Description

This is an open-label extension study based on the Phase 2 clinical trial CB03-154-EP201. The study aims to assess the long-term safety, tolerability, efficacy, and pharmacokinetics (PK) of CB03-154 at a maximum dose of 20 mg administered orally once daily (QD) in patients with epilepsy. Eligible subjects are those who successfully completed the prior CB03-154-EP201 study without early discontinuation. The treatment in this extension study will last for up to two years.

Conditions

Focal Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The Subjects from CB03-154-EP201

The subjects who completed the CB03-154-EP201 will be enrolled and begin with a two-week course of CB03-154 at 10 mg QD. Upon demonstrating good tolerability, the dose will be increased to 20 mg QD and continued for up to two years.

Group Type: EXPERIMENTAL

CB03-154

Intervention Type: DRUG

All enrolled subjects will begin with a two-week course of CB03-154 at 10 mg QD. Upon demonstrating good tolerability, the dose will be increased to 20 mg QD and continued for up to two years.

Interventions

CB03-154

All enrolled subjects will begin with a two-week course of CB03-154 at 10 mg QD. Upon demonstrating good tolerability, the dose will be increased to 20 mg QD and continued for up to two years.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhimeng Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alfred Health

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Terence O'Brien, professor

Role: CONTACT

te.obrien@alfred.org.au

0390762029

Other Identifiers

CB03-154-EP202

Identifier Type: -

Identifier Source: org_study_id