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Tests treatment safety and results for Focal Seizure
Official title Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
ClinicalTrials.gov ID: NCT06999902
What this study is testing
What is 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks?
20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal seizure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster...
- 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)...
- 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).
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- DeLand, Florida, United States
- Miami Lakes, Florida, United States
- Chicago, Illinois, United States
- Lafayette, Louisiana, United States
- Bethesda, Maryland, United States
- Chesterfield, Missouri, United States
- Ozark, Missouri, United States
- Hackensack, New Jersey, United States
- Middletown, New York, United States
- Canton, Ohio, United States
- Oklahoma City, Oklahoma, United States
- El Paso, Texas, United States
- Frisco, Texas, United States
- Round Rock, Texas, United States
- Seabrook, Texas, United States
- Barcelona, Spain
- Granda, Spain
- Madrid, Spain
- Málaga, Spain
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; DeLand, Florida, United States; Miami Lakes, Florida, United States; Chicago, Illinois, United States; Lafayette, Louisiana, United States; Bethesda, Maryland, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.