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

NCT06999902 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PRAX-628-321
• Study Type: interventional
• Target: 255
• Locations: 7 countries
• Sites: 69

Brief Summary

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

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

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 weeks DRUG

Once daily oral

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

Placebo DRUG

Once daily oral

Randomized, Double-Blind Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Praxis Precision Medicines: lead

Study Sites (69)

Praxis Research Site

Phoenix, Arizona, 85032, United States

Location

Praxis Research Site

Loma Linda, California, 92345, United States

Location

Praxis Research Site

DeLand, Florida, 32720, United States

Location

Praxis Research Site

Miami, Florida, 33133, United States

Location

Praxis Research Site

Miami Lakes, Florida, 33016, United States

Location

Praxis Research Site

Naples, Florida, 34116, United States

Location

Praxis Research Site

Orlando, Florida, 32825, United States

Location

Praxis Research Site

Chicago, Illinois, 60640, United States

Location

Praxis Research Site

Lafayette, Louisiana, 70508, United States

Location

Praxis Research Site

Bethesda, Maryland, 20817, United States

Location

Praxis Research Site

Boston, Massachusetts, 02131, United States

Location

Praxis Research Site

Plymouth, Michigan, 48170, United States

Location

Praxis Research Site

Chesterfield, Missouri, 63005, United States

Location

Praxis Research Site

Ozark, Missouri, 65721, United States

Location

Praxis Research Site

Hackensack, New Jersey, 07601, United States

Location

Praxis Research Site

Amherst, New York, 14226, United States

Location

Praxis Research Site

Middletown, New York, 10940, United States

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Praxis Research Site

New York, New York, 10016, United States

Location

Praxis Research Site

Charlotte, North Carolina, 28211, United States

Location

Praxis Research Site

Canton, Ohio, 44718, United States

Location

Praxis Research Site

Oklahoma City, Oklahoma, 73112, United States

Location

Praxis Research Site

Philadelphia, Pennsylvania, 19107, United States

Location

Praxis Research Site

Sioux Falls, South Dakota, 57105, United States

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Praxis Research Site

Memphis, Tennessee, 38104, United States

Location

Praxis Research Site

Dallas, Texas, 75206, United States

Location

Praxis Research Site

El Paso, Texas, 79912, United States

Location

Praxis Research Site

Frisco, Texas, 75034, United States

Location

Praxis Research Site

Round Rock, Texas, 78681, United States

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Praxis Research Site

Seabrook, Texas, 77586, United States

Location

Praxis Research Site

Waxahachie, Texas, 75165, United States

Location

Praxis Research Site

Virginia Beach, Virginia, 23456, United States

Location

Praxis Research Site

Campo Comprido, Curitiba PR, Brazil

Location

Praxis Research Site

Belo Horizonte, Minas Gerais, Brazil

Location

Praxis Research Site

Recife, Pernambuco, Brazil

Location

Praxis Research Site

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Praxis Research Site

Porto Alegre, Rio Grande do Sul, Brazil

Location

Praxis Research Site

Botucatu, São Paulo, Brazil

Location

Praxis Research Site

Campinas, São Paulo, Brazil

Location

Praxis Research Site

Ribeirão Preto, São Paulo, Brazil

Location

Praxis Research Site

São José do Rio Preto, São Paulo, Brazil

Location

Praxis Research Site

São Paulo, São Paulo, Brazil

Location

Praxis Research Site

Surrey, British Columbia, Canada

Location

Praxis Research Site

Toronto, Ontario, Canada

Location

Praxis Research Site

Bologna, Italy

Location

Praxis Research Site

Lecco, Italy

Location

Praxis Research Site

Milan, Italy

Location

Praxis Research Site

Monserrato, Italy

Location

Praxis Research Site

Naples, Italy

Location

Praxis Research Site

Pavia, Italy

Location

Praxis Research Site

Pisa, Italy

Location

Praxis Research Site

Ponderano, Italy

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Praxis Research Site

Pozzilli, Italy

Location

Praxis Research Site

Roma, Italy

Location

Praxis Research Site

San Lucas Tepetlacalco, Mexico

Location

Praxis Research Site

Bydgoszcz, Poland

Location

Praxis Research Site

Katowice, Poland

Location

Praxis Research Site

Lublin, Poland

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Praxis Research Site

Warsaw, Poland

Location

Praxis Research Site

Valladolid, Valladolid, Spain

Location

Praxis Research Site

Barcelona, 08003, Spain

Location

Praxis Research Site

Barcelona, 08035, Spain

Location

Praxis Research Site

Barcelona, 08041, Spain

Location

Praxis Research Site

Granda, 18012, Spain

Location

Praxis Research Site

Madrid, 28006, Spain

Location

Praxis Research Site

Madrid, 28010, Spain

Location

Praxis Research Site

Madrid, 28040, Spain

Location

Praxis Research Site

Málaga, 29010, Spain

Location

Praxis Research Site

Terrassa, 08222, Spain

Location

Praxis Research Site

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Praxis Precision Medicines

  STUDY DIRECTOR

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: May 14, 2026
• Study Completion: May 14, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

ES (11); US (31); CA (2); IT (10); ME (1); BR (10); PL (4)