PRAX-628 for Epilepsy

Recruiting at 10 trial locations

Overseen By Head of Pharmacovigilance

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Praxis Precision Medicines

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Medical Director

Principal Investigator

Praxis Precision Medicines

Eligibility Criteria

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

Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) ruling out a progressive cause of epilepsy

I have been diagnosed with focal onset or generalized tonic-clonic seizures.

I am on 1 to 3 stable seizure medications.

Exclusion Criteria

Pregnant or breastfeeding at Screening, positive serum pregnancy test at Screening, or planning pregnancy during the trial or within 14 days of the last study drug dose

Schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders

I have had specific types of seizures or seizure emergencies in the last year.

Treatment Details

Interventions

• PRAX-628 (Anti-epileptic Drug)

Trial Overview The trial is testing the effectiveness and safety of a new medication called PRAX-628 (30mg) for adults with certain types of seizures. It's an open label study where all participants know they're receiving the actual drug being tested.

Participant Groups

Group I: Open-label 30mg/day PRAX-628 for 8 weeks Experimental Treatment 1 Intervention

Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks.

Who Is Running the Clinical Trial?

Praxis Precision Medicines

Lead Sponsor

Trials

11

Recruited

1,300+