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New epilepsy drug shows promise in Long-Term safety trial

NCT ID NCT07238868

Disease control Sponsor: Shanghai Zhimeng Biopharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an investigational drug called CB03-154 in 144 people with focal epilepsy. Participants take the drug for up to two years to see if it is safe and helps reduce seizures. The goal is to find a better long-term treatment option for epilepsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CB03-154
What this could lead to
If successful, this could provide a new long-term treatment option to reduce seizure frequency in people with focal epilepsy.
What could go wrong
This is an early Phase 2 open-label study, so results may not confirm effectiveness. Side effects or lack of seizure control could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

focal epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Focal epilepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alfred Health

    RECRUITING

    Melbourne, Victoria, 3004, Australia

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