RECRUITING

Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)

Conditions

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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

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

Official Title

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

Quick Facts

Study Start:2024-12-11

Study Completion:2025-12-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06999902

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
1. A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy. 2. Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.	1. Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity. 2. Planned epilepsy surgery during the course of the clinical trial. 3. History of neurosurgery for seizures \<1 year prior to enrollment, or radiosurgery \<2 years prior to enrollment or vagus nerve stimulation (VNS) implantation. 4. History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders. 5. History of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded. 6. History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies). 7. Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening. 8. Is pregnant or is 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. 9. 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.

Inclusion Criteria

Exclusion Criteria

1. A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.
2. Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.

1. Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity.
2. Planned epilepsy surgery during the course of the clinical trial.
3. History of neurosurgery for seizures \<1 year prior to enrollment, or radiosurgery \<2 years prior to enrollment or vagus nerve stimulation (VNS) implantation.
4. History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.
5. History of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.
6. History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).
7. Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening.
8. Is pregnant or is 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.
9. 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.

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

DeLand, Florida, 32720

United States

Praxis Research Site

Miami Lakes, Florida, 33016

United States

Praxis Research Site

Chicago, Illinois, 60640

United States

Praxis Research Site

Lafayette, Louisiana, 70508

United States

Praxis Research Site

Bethesda, Maryland, 20817

United States

Praxis Research Site

Chesterfield, Missouri, 63005

United States

Praxis Research Site

Ozark, Missouri, 65721

United States

Praxis Research Site

Hackensack, New Jersey, 07601

United States

Praxis Research Site

Middletown, New York, 10940

United States

Praxis Research Site

Canton, Ohio, 44718

United States

Praxis Research Site

Oklahoma City, Oklahoma, 73112

United States

Praxis Research Site

El Paso, Texas, 79912

United States

Praxis Research Site

Frisco, Texas, 75034

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 Date2024-12-11

Study Completion Date2025-12-08

Study Record Updates

Study Start Date2024-12-11

Study Completion Date2025-12-08

Terms related to this study

Keywords Provided by Researchers

Focal Seizure

Additional Relevant MeSH Terms

Focal Seizure