Open Label Phase 2 Trial of PRAX-628 to Treat Adults With Focal Onset or Generalized Tonic-Clonic Seizures

What this Trial Is About

This research aims to evaluate the efficacy and safety of PRAX-628 in adults with focal onset seizures or primary generalized tonic-clonic seizures who are currently taking between one and three anti-seizure medications. The study is an open label clinical trial designed to assess how well PRAX-628 controls seizure frequency and its tolerability in this population. Participants who qualify will receive 30 mg of PRAX-628 orally once daily for a period of 8 weeks. This single treatment group will allow researchers to observe the effects of PRAX-628 without a placebo or comparison group. The study focuses on adults aged 18 to 75 years and excludes those with certain medical histories or conditions that might interfere with the trial. During the 8-week treatment, participants will be monitored for seizure frequency and changes in clinical global impressions of severity as well as patient global impressions. Safety and tolerability will be carefully tracked throughout the study. The main outcome is the change in seizure frequency, with additional assessments of symptom severity and side effects. Participation involves regular visits and evaluations to ensure thorough monitoring of responses to PRAX-628.

An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures