CB03: add-on therapy for focal epilepsy
Epilepsy is a common neurological disorder that affects around 90 million people worldwide, causing seizures and significantly impacting patients and their families. Treatment aims to control seizures, avoid side effects, and improve quality of life, but about 30% of cases are resistant to current antiepileptic drugs. Newer treatments like CB03-154, a potassium channel opener, show promise in treating these resistant cases, offering better stability, safety, and fewer side effects compared to older drugs like RTG. The primary objectives of the proposed study are to evaluate the efficacy of CB03-154 compared to placebo on focal seizure frequency and to assess the safety and tolerability of CB03-154 in adults with focal epilepsy taking 1 to 3 anti-epileptic drugs (AEDs) during the double-blind period (DBP). Secondary objectives include evaluating the 50% response rate to CB03-154, assessing seizure severity and impact, analyzing trends in seizure frequency, and determining the pharmacokinetic (PK) profile of CB03-154.
What you need to know
Who can take part?
You may be eligible to participate in this study if you:
- Are 18 years of age or older
- Have a diagnosis of Focal Epilepsy (>2 years)
- Have ≥6 countable seizures in 2 months
- Have tried two or more anti-seizures medications but did not achieve sustained freedom from seizures.
People with certain medical conditions or taking some medications may not be eligible for this study. People who are considering becoming a mother or father during the study are not eligible to participate. The study staff will discuss the eligibility criteria with you if you are interested in taking part.
What is involved for me?
Study participants will be randomly assigned to receive the study drug or placebo in addition to their existing anti-epileptic medications, for a period of 14 weeks. Neither you, nor the Mater clinical trial team will know whether you are receiving study drug or placebo. This is necessary to provide strong scientific evidence regarding drug effects. All participants will have the opportunity to receive the investigational medication after completion of the trial (14 weeks), independently of their group of origin (placebo versus study drug)
Participants will also undertake the following procedures, tests and assessments:
- Physical exam and medical history
- Neurological exams
- Health and wellbeing questionnaires
- Reasoning and thinking assessments
- Electrocardiograms (ECG)
- Ultrasound for bladder and/or lower extremities
- Pregnancy tests if applicable
- Blood tests
- Urine tests
- Keep a seizure diary
Trial dates
February 2025 - June 2026
