Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
NCT ID: NCT06999902
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
230 participants
INTERVENTIONAL
2024-12-11
2025-12-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628
Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of PRAX-628 for 6 weeks followed by 30 mg PRAX 628 for the remaining 6 weeks.
20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
Once daily oral
Randomized, Double-Blind Placebo
Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive a matching placebo throughout the 12-week Treatment Period
Placebo
Once daily oral
Interventions
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20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
Once daily oral
Placebo
Once daily oral
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Praxis Precision Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Praxis Precision Medicines
Locations
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Praxis Research Site
Phoenix, Arizona, United States
Praxis Research Site
DeLand, Florida, United States
Praxis Research Site
Miami Lakes, Florida, United States
Praxis Research Site
Chicago, Illinois, United States
Praxis Research Site
Lafayette, Louisiana, United States
Praxis Research Site
Bethesda, Maryland, United States
Praxis Research Site
Chesterfield, Missouri, United States
Praxis Research Site
Ozark, Missouri, United States
Praxis Research Site
Hackensack, New Jersey, United States
Praxis Research Site
Middletown, New York, United States
Praxis Research Site
Canton, Ohio, United States
Praxis Research Site
Oklahoma City, Oklahoma, United States
Praxis Research Site
El Paso, Texas, United States
Praxis Research Site
Frisco, Texas, United States
Praxis Research Site
Round Rock, Texas, United States
Praxis Research Site
Seabrook, Texas, United States
Praxis Research Site
Barcelona, , Spain
Praxis Research Site
Barcelona, , Spain
Praxis Research Site
Barcelona, , Spain
Praxis Research Site
Granda, , Spain
Praxis Research Site
Madrid, , Spain
Praxis Research Site
Madrid, , Spain
Praxis Research Site
Madrid, , Spain
Praxis Research Site
Málaga, , Spain
Praxis Research Site
Terrassa, , Spain
Praxis Research Site
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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PRAX-628-321
Identifier Type: -
Identifier Source: org_study_id