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A Double-Blind, Randomized, Multicenter Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
Led by Praxis Precision Medicines · Updated on 2025-05-31
230
Participants Needed
26
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates PRAX-628, a medication being studied for adults with focal seizures who are currently taking between one and three anti-seizure medications. The trial is designed as a double-blind, randomized, multicenter study to assess the medication's safety and how well it works in reducing seizure frequency. The study is sponsored by Praxis Precision Medicines and focuses on adults aged 18 to 75 with a confirmed diagnosis of focal onset epilepsy. Participants are randomly assigned to one of two groups. One group receives PRAX-628 orally once daily, starting with 20 mg for the first six weeks, then increasing to 30 mg for the next six weeks. The other group receives a matching placebo once daily for the entire 12-week treatment period. The study is carefully controlled to keep participants and researchers unaware of the assigned treatment to accurately evaluate outcomes. During the 12-week treatment period, participants will be monitored regularly to assess seizure frequency, safety, and tolerability of the medication. Researchers will use imaging tests like CT or MRI to confirm eligibility before enrollment and exclude participants with certain medical histories. The primary measure is the change in focal seizure frequency over the 12 weeks. The study includes safety checks, and all participants' health will be closely observed throughout the trial until its completion in December 2025.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years
- Diagnosed with focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification
- Past CT or MRI imaging showing no progressive cause of epilepsy
- Currently taking at least 1 and no more than 3 acceptable anti-seizure medications
You will not qualify if you...
- History within 12 months of pseudo or psychogenic seizures, uncountable cluster seizures, convulsive status epilepticus requiring hospitalization and intubation, or only focal seizures with awareness without motor activity
- Planned epilepsy surgery during the trial
- Neurosurgery for seizures less than 1 year before enrollment, radiosurgery less than 2 years before enrollment, or vagus nerve stimulation 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
- History of cardiac disease, cardiac conduction disorders, or cardiac structural abnormalities
- Positive test or known history of HIV, hepatitis B surface antigen, or hepatitis C virus antibody at screening
- Pregnant, breastfeeding, positive pregnancy test at screening, or planning pregnancy during the trial or within 14 days after last study drug dose
- Use of any other experimental drug, device, or gene therapy within 30 days or 5 half-lives prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants take either PRAX-628 or placebo once daily. The dose of PRAX-628 starts at 20 mg per day for 6 weeks, then increases to 30 mg per day for the remaining 6 weeks.
Visits as required for dosing and safety monitoring
Trial Site Locations
Total: 26 locations
1
Praxis Research Site
Phoenix, Arizona, United States, 85032
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2
Praxis Research Site
DeLand, Florida, United States, 32720
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3
Praxis Research Site
Miami Lakes, Florida, United States, 33016
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4
Praxis Research Site
Chicago, Illinois, United States, 60640
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5
Praxis Research Site
Lafayette, Louisiana, United States, 70508
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6
Praxis Research Site
Bethesda, Maryland, United States, 20817
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7
Praxis Research Site
Chesterfield, Missouri, United States, 63005
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8
Praxis Research Site
Ozark, Missouri, United States, 65721
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9
Praxis Research Site
Hackensack, New Jersey, United States, 07601
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10
Praxis Research Site
Middletown, New York, United States, 10940
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11
Praxis Research Site
Canton, Ohio, United States, 44718
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12
Praxis Research Site
Oklahoma City, Oklahoma, United States, 73112
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13
Praxis Research Site
El Paso, Texas, United States, 79912
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14
Praxis Research Site
Frisco, Texas, United States, 75034
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15
Praxis Research Site
Round Rock, Texas, United States, 78681
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16
Praxis Research Site
Seabrook, Texas, United States, 77586
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17
Praxis Research Site
Barcelona, Spain, 08003
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18
Praxis Research Site
Barcelona, Spain, 08035
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19
Praxis Research Site
Barcelona, Spain, 08041
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20
Praxis Research Site
Granda, Spain, 18012
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21
Praxis Research Site
Madrid, Spain, 28006
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22
Praxis Research Site
Madrid, Spain, 28010
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23
Praxis Research Site
Madrid, Spain, 28040
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24
Praxis Research Site
Málaga, Spain, 29010
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25
Praxis Research Site
Terrassa, Spain, 08222
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26
Praxis Research Site
Valencia, Spain, 46026
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Research Team
H
Head of Pharmacovigilance
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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