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

Last updated: May 23, 2025
Sponsor: Praxis Precision Medicines
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks

Placebo

Clinical Study ID

NCT06999902
PRAX-628-321
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A diagnosis of focal onset epilepsy according to the International League AgainstEpilepsy (ILAE) Classification of Epilepsy.

  2. Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) thathas ruled out a progressive cause of epilepsy in the judgement of the investigatorand/or in consultation with the medical monitor.

Exclusion

Exclusion Criteria:

  1. Subject has had any of the of the following within the 12-month period precedingtrial entry: History of pseudo or psychogenic seizures, cluster seizures where theindividual seizures cannot be counted, an episode of convulsive status epilepticusrequiring hospitalization and intubation, or subject only has focal seizures withawareness 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 <2years prior to enrollment or vagus nerve stimulation (VNS) implantation.

  4. History of schizophrenia, obsessive-compulsive disorder, or other serious mentalhealth disorders.

  5. History of malignancy, myeloproliferative or lymphoproliferative disorders withinthe past 5 years are excluded.

  6. History of cardiac disease(s)/cardiac conduction disorders/or cardiac structuralabnormality(ies).

  7. Has a positive test result or a known history of a positive test result for humanimmunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitisC virus (HCV) antibody at Screening.

  8. Is pregnant or is breastfeeding at the time of Screening or has a positive serumpregnancy test at Screening or is planning to become pregnant during the clinicaltrial or within 14 days of the last study drug dose.

  9. Has received any other experimental or investigational drug, device or other therapywithin 30 days or 5 half-lives (whichever is longer) prior to Screening, or anyprior use of gene therapy.

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
Phase: 2/3
Study Start date:
December 11, 2024
Estimated Completion Date:
December 08, 2025

Study Description

PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.

Connect with a study center

  • Praxis Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Praxis Research Site

    Granda, 18012
    Spain

    Active - Recruiting

  • Praxis Research Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Praxis Research Site

    Málaga, 29010
    Spain

    Active - Recruiting

  • Praxis Research Site

    Terrassa, 08222
    Spain

    Active - Recruiting

  • Praxis Research Site

    Valencia, 46026
    Spain

    Active - Recruiting

  • Praxis Research Site

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Praxis Research Site

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Praxis Research Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Praxis Research Site

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Praxis Research Site

    Lafayette, Louisiana 70508
    United States

    Active - Recruiting

  • Praxis Research Site

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Praxis Research Site

    Chesterfield, Missouri 63005
    United States

    Active - Recruiting

  • Praxis Research Site

    Ozark, Missouri 65721
    United States

    Active - Recruiting

  • Praxis Research Site

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Praxis Research Site

    Middletown, New York 10940
    United States

    Active - Recruiting

  • Praxis Research Site

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Praxis Research Site

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Praxis Research Site

    El Paso, Texas 79912
    United States

    Active - Recruiting

  • Praxis Research Site

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • Praxis Research Site

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Praxis Research Site

    Seabrook, Texas 77586
    United States

    Active - Recruiting

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