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PRAX-628 for Focal Onset or Tonic-Clonic Seizures

This study is testing a drug called PRAX-628 to see how well it works and if it's safe for adults with focal onset seizures or primary generalized tonic-clonic seizures. You could be eligible if you are between 18 and 75 years old, have a diagnosis of these seizure types, and are currently taking 1 to 3 anti-seizure medications at stable doses. The main goal is to see if PRAX-628 can reduce how often you have seizures over 8 weeks. This study is currently unclear on its recruitment status and plans to enroll about 50 participants.

Study design
This is an open-label study, meaning both you and your doctors will know you are receiving PRAX-628. It plans to enroll about 50 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures seizure frequency at 8 weeks, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06908356

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Praxis Precision Medicines
~50 participants
Updated 2025-04-03 on ClinicalTrials.gov
What's tested:30mg PRAX-628

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs
Measured over 8 weeks

Conditions

Focal Onset Seizure
Primary Generalized Epilepsy

Explore related trials

Partial SeizurePrimary Generalized Epilepsy

Where it's being run

11 sites across 9 states
Texas2
Australia2
Arizona1
Florida1
Maryland1
Missouri1
New Jersey1
New York1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Praxis Precision Medicines

Who to contact

Head of Pharmacovigilance
[email protected]
617-300-8460
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs8 weeks

    Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628