An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients with Focal Onset or Primary Generalized Tonic-Clonic Seizures
PRAX-628 is a new medication being developed to treat epilepsy, focusing on focal onset seizures and primary generalized tonic-clonic seizures (PGTCS). PRAX-628 selectively targets the overactive brain cells, potentially reducing side effects while improving effectiveness. The primary objective of the PRAX-628-212 trial is to evaluate how well the drug reduces the frequency of focal onset and PGTCS seizures over an 8-week period. Secondary objectives include assessing its safety, how well patients tolerate it, and how quickly it reaches effective levels without needing dose adjustments. Early trials have shown promising results, with minimal side effects reported. This medication could offer a more precise and better-tolerated option for people with epilepsy than existing treatments.
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 ≥2 countable Focal Onset Seizures in 1 month OR have ≥1 countable Primary Generalised Tonic-Clonic Seizure in 1 month, and for 3 months in a row prior signature of consent
- 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 8 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 investigatio.nal medication after completion of the trial (up to 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
- Electrocardiograms (ECG)
- Pregnancy tests if applicable
- Blood tests
- Urine tests
- Keep a seizure diary
- Genotyping (optional)
- Neuroimaging (if not done in past 5 years)
