RECRUITING

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

Conditions

Focal Onset Seizure Primary Generalized Epilepsy Tonic-Clonic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-10

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06908356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Head of Pharmacovigilance

CONTACT

617-300-8460

clinicaltrials@praxismedicines.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Praxis Precision Medicines

Study Locations (Sites)

Praxis Research Site

Phoenix, Arizona, 85032

United States

Praxis Research Site

Miami Lakes, Florida, 30116

United States

Praxis Research Site

Bethesda, Maryland, 20817

United States

Praxis Research Site

Chesterfield, Missouri, 63005

United States

Praxis Research Site

Hackensack, New Jersey, 07601

United States

Praxis Research Site

Middletown, New York, 10941

United States

Praxis Research Site

Round Rock, Texas, 78681

United States

Praxis Research Site

Seabrook, Texas, 77586

United States

Collaborators and Investigators

Sponsor: Praxis Precision Medicines

Medical Director, STUDY_DIRECTOR, Praxis Precision Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-10

Study Completion Date2025-07

Study Record Updates

Study Start Date2025-01-10

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Focal Onset Seizure
Primary Generalized Epilepsy
Tonic-Clonic

Additional Relevant MeSH Terms

Focal Onset Seizure
Primary Generalized Epilepsy