NCT06999902

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_2

Geographic Reach
2 countries

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

March 14, 2025

Last Update Submit

May 23, 2025

Conditions

Focal Seizure

Keywords

Focal Seizure

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs

    Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared to placebo.

    12 weeks

Secondary Outcomes (11)

  • To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs

    12 weeks

  • To assess trends over time in efficacy of PRAX 628 on focal seizure frequency

    12 weeks

  • To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs

    12 weeks

  • To assess the safety and tolerability of PRAX-628 in adults with focal seizures

    12 weeks

  • To assess the safety and tolerability of PRAX-628 in adults with focal seizures

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628

EXPERIMENTAL

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.

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

Randomized, Double-Blind Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

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

Once daily oral

Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628
PlaceboDRUG

Once daily oral

Randomized, Double-Blind Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 the investigator and/or in consultation with the medical monitor.

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Praxis Research Site

Phoenix, Arizona, 85032, United States

RECRUITING

Praxis Research Site

DeLand, Florida, 32720, United States

RECRUITING

Praxis Research Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Praxis Research Site

Chicago, Illinois, 60640, United States

RECRUITING

Praxis Research Site

Lafayette, Louisiana, 70508, United States

RECRUITING

Praxis Research Site

Bethesda, Maryland, 20817, United States

RECRUITING

Praxis Research Site

Chesterfield, Missouri, 63005, United States

RECRUITING

Praxis Research Site

Ozark, Missouri, 65721, United States

RECRUITING

Praxis Research Site

Hackensack, New Jersey, 07601, United States

RECRUITING

Praxis Research Site

Middletown, New York, 10940, United States

RECRUITING

Praxis Research Site

Canton, Ohio, 44718, United States

RECRUITING

Praxis Research Site

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Praxis Research Site

El Paso, Texas, 79912, United States

RECRUITING

Praxis Research Site

Frisco, Texas, 75034, United States

RECRUITING

Praxis Research Site

Round Rock, Texas, 78681, United States

RECRUITING

Praxis Research Site

Seabrook, Texas, 77586, United States

RECRUITING

Praxis Research Site

Barcelona, 08003, Spain

RECRUITING

Praxis Research Site

Barcelona, 08035, Spain

RECRUITING

Praxis Research Site

Barcelona, 08041, Spain

RECRUITING

Praxis Research Site

Granda, 18012, Spain

RECRUITING

Praxis Research Site

Madrid, 28006, Spain

RECRUITING

Praxis Research Site

Madrid, 28010, Spain

RECRUITING

Praxis Research Site

Madrid, 28040, Spain

RECRUITING

Praxis Research Site

Málaga, 29010, Spain

RECRUITING

Praxis Research Site

Terrassa, 08222, Spain

RECRUITING

Praxis Research Site

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Praxis Precision Medicines

    STUDY DIRECTOR

Central Study Contacts

Head of Pharmacovigilance

CONTACT

617-300-8460clinicaltrials@praxismedicines.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

May 31, 2025

Study Start

December 11, 2024

Primary Completion

November 24, 2025

Study Completion

December 8, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations

ES(10)US(16)