Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)

Launched by PRAXIS PRECISION MEDICINES · May 23, 2025

Keywords

ClinConnect Summary

The POWER1 clinical trial is studying a new medication called PRAX-628 to see if it can help adults with focal seizures, which are a type of epilepsy that starts in one area of the brain. The trial is currently looking for participants aged 18 to 80 who have been diagnosed with focal onset epilepsy and have had tests like CT or MRI scans to rule out other causes for their seizures. Unfortunately, there are some exclusions, such as recent history of certain types of seizures or other serious health conditions.

If you choose to participate in the trial, you will be randomly assigned to receive either the study drug or a placebo (a pill that has no active medication). This means that neither you nor the researchers will know which one you are getting, which helps ensure the results are unbiased. Throughout the study, you will be monitored closely for any effects of the medication and to see how well it works. It's a chance to contribute to important research that could help others with similar conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.
• • 2. Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
• Exclusion Criteria:
• • 1. Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity.
• • 2. Planned epilepsy surgery during the course of the clinical trial.
• • 3. History of neurosurgery for seizures \<1 year prior to enrollment, or radiosurgery \<2 years prior to enrollment or vagus nerve stimulation (VNS) implantation.
• • 4. History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.
• • 5. History of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.
• • 6. History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).
• • 7. Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening.
• • 8. Is pregnant or is breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose.
• • 9. Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy.