PRAX-628 for Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called PRAX-628, a potential anti-seizure medication, for people with specific types of epilepsy. It focuses on evaluating the treatment's effectiveness and safety. The study targets individuals who experience focal onset seizures (seizures starting in one part of the brain) or primary generalized tonic-clonic seizures (seizures affecting the whole brain) and have frequent episodes despite treatment with up to three anti-seizure medications. Participants will take 30mg of PRAX-628 daily for 8 weeks. Those with frequent seizures as described and stable medication doses might find this trial suitable. As a Phase 2 trial, it measures PRAX-628's effectiveness in an initial, smaller group, offering a chance to contribute to important research.
Will I have to stop taking my current medications?
The trial does not specify that you need to stop taking your current medications. In fact, you must be on stable doses of 1 to 3 allowable anti-seizure medications (ASMs) to participate.
Is there any evidence suggesting that PRAX-628 is likely to be safe for humans?
Research has shown that PRAX-628 was well-tolerated in earlier studies. In one study, researchers safely administered it to healthy individuals at doses more than 15 times higher than the expected regular use. This indicates a strong safety profile. Another study found that high doses of PRAX-628 significantly improved seizure-related events without causing serious side effects. Overall, these findings suggest that PRAX-628 is generally safe for humans.12345
Why do researchers think this study treatment might be promising for epilepsy?
Researchers are excited about PRAX-628 for epilepsy because it offers a fresh approach to managing seizures. Unlike standard treatments like valproate and lamotrigine, which often work by stabilizing electrical activity in the brain, PRAX-628 targets specific neuronal pathways with a novel mechanism aimed at reducing hyperexcitability more precisely. This targeted action could potentially lead to fewer side effects and improved seizure control, making it a promising option for patients who haven't found relief with current medications.
What evidence suggests that PRAX-628 might be an effective treatment for epilepsy?
Research has shown that PRAX-628, the investigational treatment in this trial, may help treat seizures. In earlier studies, patients who took PRAX-628 experienced a noticeable drop in seizure activity. One study even found that it completely stopped certain brain reactions to light that can cause seizures. PRAX-628 has also reduced various types of seizures, such as those affecting movement and muscle control. These results suggest that PRAX-628 could be a strong treatment option for people with specific types of seizures, like focal onset or primary generalized tonic-clonic seizures.12367
Who Is on the Research Team?
Medical Director
Principal Investigator
Praxis Precision Medicines
Are You a Good Fit for This Trial?
Adults with focal onset or tonic-clonic seizures who have had at least 2 seizures per month and are on stable epilepsy medication can join. Those pregnant, planning pregnancy, with serious mental health issues, recent neurosurgery, cardiac problems, cancer history within 5 years, or recent experimental therapy use cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 30mg/day of PRAX-628 for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PRAX-628
Find a Clinic Near You
Who Is Running the Clinical Trial?
Praxis Precision Medicines
Lead Sponsor