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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Head of Pharmacovigilance
• Email: clinicaltrials@praxismedicines.com
• Phone: 617-300-8460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.