An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients with Primary Generalized Tonic-Clonic Seizures
PRAX-628 is a new medication being developed to treat epilepsy, focusing on primary generalized tonic-clonic seizures (PGTCS) and focal onset seizures (Focal Epilepsy population now closed to recruitment). PRAX-628 selectively targets the overactive 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 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 ≥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
receiving the study drug in addition to their existing anti-epileptic medications, for a period of 8 weeks. - All participants will have the opportunity to continue taking the investigatinal medication after completion of the trial.
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)
