An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
RecruitingPhase 2
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
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * A diagnosis of focal onset seizures or idiopathic generalized tonic clonic seizures. * Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) in the past that has ruled out a progressive cause of epilepsy. * Participant must have been receiving stable doses of allowable ASMs (a minimum of 1 and a maximum of 3 ASMs). * Participant and/or caregiver (if applicable) self-reports at least 2 countable focal onset seizures per month for focal onset patients, or 1 countable generalized tonic-clonic seizure per month in the 3 months immediately prior to the Screening/Observation Period for PGTCS patients. Exclusion Criteria: * History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures cannot be counted, or an episode of convulsive status epilepticus requiring hospitalization and intubation in the 12 months prior to Screening. * Planned epilepsy surgery during the course of the clinical trial. * History of neurosurgery for seizures \<1 year prior to enrollment, or radiosurgery \<2 years prior to enrollment. * Schizophrenia and obsessive-compulsive disorder, or other serious mental health disorders. * Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt. * Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded. * History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies). * Is pregnant or 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. * 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. * Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin. * Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to Screening.
About the study
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
What is being tested
- 30mg PRAX-628 (drug)
Sponsor: Praxis Precision Medicines · Participants: 50 · Started: Jan 10, 2025
Contact the study team
- Head of Pharmacovigilance · Phone: 617-300-8460
Official record on ClinicalTrials.gov — NCT06908356
Locations in the U.S.
| Arizona | Praxis Research Site, Phoenix |
| Florida | Praxis Research Site, Miami Lakes |
| Maryland | Praxis Research Site, Bethesda |
| Missouri | Praxis Research Site, Chesterfield |
| New Jersey | Praxis Research Site, Hackensack |
| New York | Praxis Research Site, Middletown |
| Texas | Praxis Research Site, Round Rock Praxis Research Site, Seabrook |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.