Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.
- 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.
You will not qualify if you...
- 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.
- 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 or vagus nerve stimulation (VNS) implantation.
- History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.
- 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).
- 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.
- 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.
- 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
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
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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
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
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