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

NCT07238868 | Recruiting Phase 2

• 1 other identifier: CB03-154-EP202
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (2)

• To assess the long-term tolerability and safety of CB03-154 in patients diagnosed with epilepsy.

  Severity and frequency of associated AEs/serious adverse events (SAEs)

  In the entire period of the whole study, including a treatment period up to 2 years (104 weeks) and a post treatment follow-up period of 8 weeks.

• To assess the long-term efficacy of CB03-154 in patients diagnosed with epilepsy.

  Median percent change (MPC) in monthly (28 days) seizure frequency from baseline (the end of the DBP of study CB03 154-EP201) to the entire treatment period.

  In the entire period of the whole study, including a treatment period up to 2 years (104 weeks) and a post treatment follow-up period of 8 weeks.

Secondary Outcomes (1)

• Maximum Plasma Concentration (Cmax).

  In the Week 2±3 days , Week 4±3 days , Week 13±3 days , and Week 26±7 days.

Study Arms (1)

The Subjects from CB03-154-EP201

EXPERIMENTAL

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.

Drug: CB03-154

Interventions

CB03-154 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.

The Subjects from CB03-154-EP201

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \- 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.
• \. 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.

Sponsors & Collaborators

• Shanghai Zhimeng Biopharma, Inc.: lead

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Terence O'Brien, professor

CONTACT

0390762029; te.obrien@alfred.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)