Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT06999902

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

Led by Praxis Precision Medicines · Updated on 2025-05-31

230

Participants Needed

26

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 26 locations

1

Praxis Research Site

Phoenix, Arizona, United States, 85032

Actively Recruiting

2

Praxis Research Site

DeLand, Florida, United States, 32720

Actively Recruiting

3

Praxis Research Site

Miami Lakes, Florida, United States, 33016

Actively Recruiting

4

Praxis Research Site

Chicago, Illinois, United States, 60640

Actively Recruiting

5

Praxis Research Site

Lafayette, Louisiana, United States, 70508

Actively Recruiting

6

Praxis Research Site

Bethesda, Maryland, United States, 20817

Actively Recruiting

7

Praxis Research Site

Chesterfield, Missouri, United States, 63005

Actively Recruiting

8

Praxis Research Site

Ozark, Missouri, United States, 65721

Actively Recruiting

9

Praxis Research Site

Hackensack, New Jersey, United States, 07601

Actively Recruiting

10

Praxis Research Site

Middletown, New York, United States, 10940

Actively Recruiting

11

Praxis Research Site

Canton, Ohio, United States, 44718

Actively Recruiting

12

Praxis Research Site

Oklahoma City, Oklahoma, United States, 73112

Actively Recruiting

13

Praxis Research Site

El Paso, Texas, United States, 79912

Actively Recruiting

14

Praxis Research Site

Frisco, Texas, United States, 75034

Actively Recruiting

15

Praxis Research Site

Round Rock, Texas, United States, 78681

Actively Recruiting

16

Praxis Research Site

Seabrook, Texas, United States, 77586

Actively Recruiting

17

Praxis Research Site

Barcelona, Spain, 08003

Actively Recruiting

18

Praxis Research Site

Barcelona, Spain, 08035

Actively Recruiting

19

Praxis Research Site

Barcelona, Spain, 08041

Actively Recruiting

20

Praxis Research Site

Granda, Spain, 18012

Actively Recruiting

21

Praxis Research Site

Madrid, Spain, 28006

Actively Recruiting

22

Praxis Research Site

Madrid, Spain, 28010

Actively Recruiting

23

Praxis Research Site

Madrid, Spain, 28040

Actively Recruiting

24

Praxis Research Site

Málaga, Spain, 29010

Actively Recruiting

25

Praxis Research Site

Terrassa, Spain, 08222

Actively Recruiting

26

Praxis Research Site

Valencia, Spain, 46026

Actively Recruiting

Loading map...

Research Team

H

Head of Pharmacovigilance

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here