Actively Recruiting
A Multicenter, Open-label, Long-term Safety, Tolerability, and Efficacy Study of CB03-154 in Subjects Diagnosed With Epilepsy
Led by Shanghai Zhimeng Biopharma, Inc. · Updated on 2025-11-20
144
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CB03-154, an investigational drug developed by Shanghai Zhimeng Biopharma Inc., for the treatment of focal epilepsy. This open-label extension study follows a Phase 2 trial and aims to assess the long-term safety, tolerability, efficacy, and pharmacokinetics of CB03-154 when given orally once daily to patients with epilepsy. Only patients who successfully completed the prior study without early discontinuation are eligible to participate. Participants will start with a two-week course of CB03-154 at 10 mg once daily. If the medication is well tolerated, the dose will be increased to 20 mg once daily and continued for up to two years. This study focuses on long-term treatment and monitoring of patients who have already been treated in the previous trial. Throughout the study, participants will be monitored for safety, tolerability, and effectiveness of CB03-154, including the measurement of plasma drug concentration at specified weeks. Patients will keep seizure diaries and attend regular visits during the treatment period, which lasts up to 104 weeks, followed by an 8-week post-treatment follow-up. The study will evaluate how well patients tolerate the drug and its long-term impact on epilepsy symptoms.
CONDITIONS
Brief Title
An Open-label Study to Evaluate Safety, Tolerability, and Efficacy of CB03-154 in Subjects Diagnosed With Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has given written informed consent before entering the study.
- Completed the CB03-154-EP201 study without early termination and met all eligibility requirements.
- No significant protocol deviations or adverse events preventing study entry.
- Able to understand and follow verbal and written instructions.
- Able to keep accurate seizure diaries.
You will not qualify if you...
- Met any withdrawal criteria during the CB03-154-EP201 study.
- Has any medical condition, personal circumstance, or ongoing adverse event that poses unacceptable risk or prevents protocol adherence.
- Plans to join another clinical trial with an investigational drug or use an experimental device for epilepsy treatment during this study and for 28 days after.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants begin with a two-week course of CB03-154 at 10 mg once daily. Upon demonstrating good tolerability, the dose is increased to 20 mg once daily and continued for up to two years.
Visits at Week 2, Week 4, Week 13, and Week 26 for assessments
Duration - 8 weeks
Participants are monitored for safety and efficacy for 8 weeks after treatment ends.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
T
Terence O'Brien, professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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