Evaluating PRAX-628 for treating focal onset and tonic-clonic seizures in adults

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

This study is testing a new medication called PRAX-628 to see if it can help adults with focal onset or tonic-clonic seizures better control their symptoms while they are already on other seizure medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Praxis Precision Medicines (Industry-sponsored)
• Locations: 11 sites (Phoenix, Arizona and 10 other locations)
• Trial ID: NCT06908356 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of PRAX-628, a new medication, in adults suffering from focal onset seizures or primary generalized tonic-clonic seizures. Participants must be on stable doses of one to three anti-seizure medications and have a documented history of seizures. The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study aims to determine how well PRAX-628 can control seizures compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with focal onset seizures or primary generalized tonic-clonic seizures who are currently on stable doses of anti-seizure medications.

Not a fit: Patients with a history of pseudo or psychogenic seizures or those planning epilepsy surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide better seizure control for patients with difficult-to-treat epilepsy.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of PRAX-628 is being evaluated for the first time.

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.

Where this trial is running

Phoenix, Arizona and 10 other locations

• Praxis Research Site — Phoenix, Arizona, United States (Recruiting)
• Praxis Research Site — Miami Lakes, Florida, United States (Recruiting)
• Praxis Research Site — Bethesda, Maryland, United States (Recruiting)
• Praxis Research Site — Chesterfield, Missouri, United States (Recruiting)
• Praxis Research Site — Hackensack, New Jersey, United States (Recruiting)
• Praxis Research Site — Middletown, New York, United States (Recruiting)
• Praxis Research Site — Round Rock, Texas, United States (Recruiting)
• Praxis Research Site — Seabrook, Texas, United States (Recruiting)
• Praxis Research Site — Heidelberg, Australia (Recruiting)
• Praxis Research Site — Melbourne, Australia (Recruiting)
• Praxis Research Site — Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Head of Pharmacovigilance

Conditions Focal Onset Seizure; Primary Generalized Epilepsy; Tonic-Clonic