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Can a new daily pill tame focal seizures?

NCT ID NCT06999902

Disease control Sponsor: Praxis Precision Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is testing whether an experimental medication called PRAX-628 can reduce the frequency of focal seizures in adults with epilepsy who are already taking one to three other seizure medications. Participants will receive either PRAX-628 or a placebo for 12 weeks, with the dose increasing after the first 6 weeks. The main goal is to see if PRAX-628 leads to a greater reduction in monthly seizure frequency compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRAX-628, an experimental oral medication taken once daily
What this could lead to
If successful, PRAX-628 could offer a new treatment option to help reduce focal seizures in adults with epilepsy who still have seizures despite taking other medications.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove more effective than placebo. As with any new medication, there is also a risk of unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

255 people

The number who actually took part.

Started

Dec 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy. 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: 1. 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. 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.

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Conditions

The condition(s) this trial relates to.

focal epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Focal seizure

Contacts and locations

Locations

  • Praxis Research Site

    DeLand, Florida, 32720, United States

  • Praxis Research Site

    Miami, Florida, 33133, United States

  • Praxis Research Site

    Miami Lakes, Florida, 33016, United States

  • Praxis Research Site

    Naples, Florida, 34116, United States

  • Praxis Research Site

    Orlando, Florida, 32825, United States

  • Praxis Research Site

    Chicago, Illinois, 60640, United States

  • Praxis Research Site

    Lafayette, Louisiana, 70508, United States

  • Praxis Research Site

    Bethesda, Maryland, 20817, United States

  • Praxis Research Site

    Boston, Massachusetts, 02131, United States

  • Praxis Research Site

    Plymouth, Michigan, 48170, United States

  • Praxis Research Site

    Chesterfield, Missouri, 63005, United States

  • Praxis Research Site

    Ozark, Missouri, 65721, United States

  • Praxis Research Site

    Hackensack, New Jersey, 07601, United States

  • Praxis Research Site

    Amherst, New York, 14226, United States

  • Praxis Research Site

    Middletown, New York, 10940, United States

  • Praxis Research Site

    New York, New York, 10016, United States

  • Praxis Research Site

    Charlotte, North Carolina, 28211, United States

  • Praxis Research Site

    Canton, Ohio, 44718, United States

  • Praxis Research Site

    Oklahoma City, Oklahoma, 73112, United States

  • Praxis Research Site

    Philadelphia, Pennsylvania, 19107, United States

  • Praxis Research Site

    Sioux Falls, South Dakota, 57105, United States

  • Praxis Research Site

    Memphis, Tennessee, 38104, United States

  • Praxis Research Site

    Dallas, Texas, 75206, United States

  • Praxis Research Site

    El Paso, Texas, 79912, United States

  • Praxis Research Site

    Frisco, Texas, 75034, United States

  • Praxis Research Site

    Round Rock, Texas, 78681, United States

  • Praxis Research Site

    Seabrook, Texas, 77586, United States

  • Praxis Research Site

    Waxahachie, Texas, 75165, United States

  • Praxis Research Site

    Virginia Beach, Virginia, 23456, United States

  • Praxis Research Site

    Campo Comprido, Curitiba PR, Brazil

  • Praxis Research Site

    Belo Horizonte, Minas Gerais, Brazil

  • Praxis Research Site

    Recife, Pernambuco, Brazil

  • Praxis Research Site

    Rio de Janeiro, Rio de Janeiro, Brazil

  • Praxis Research Site

    Porto Alegre, Rio Grande do Sul, Brazil

  • Praxis Research Site

    Botucatu, São Paulo, Brazil

  • Praxis Research Site

    Campinas, São Paulo, Brazil

  • Praxis Research Site

    Ribeirão Preto, São Paulo, Brazil

  • Praxis Research Site

    São José do Rio Preto, São Paulo, Brazil

  • Praxis Research Site

    São Paulo, São Paulo, Brazil

  • Praxis Research Site

    Surrey, British Columbia, Canada

  • Praxis Research Site

    Toronto, Ontario, Canada

  • Praxis Research Site

    Bologna, Italy

  • Praxis Research Site

    Lecco, Italy

  • Praxis Research Site

    Milan, Italy

  • Praxis Research Site

    Monserrato, Italy

  • Praxis Research Site

    Naples, Italy

  • Praxis Research Site

    Pavia, Italy

  • Praxis Research Site

    Pisa, Italy

  • Praxis Research Site

    Ponderano, Italy

  • Praxis Research Site

    Pozzilli, Italy

  • Praxis Research Site

    Roma, Italy

  • Praxis Research Site

    San Lucas Tepetlacalco, Mexico

  • Praxis Research Site

    Bydgoszcz, Poland

  • Praxis Research Site

    Katowice, Poland

  • Praxis Research Site

    Lublin, Poland

  • Praxis Research Site

    Warsaw, Poland

  • Praxis Research Site

    Valladolid, Valladolid, Spain

  • Praxis Research Site

    Barcelona, 08003, Spain

  • Praxis Research Site

    Barcelona, 08035, Spain

  • Praxis Research Site

    Barcelona, 08041, Spain

  • Praxis Research Site

    Granda, 18012, Spain

  • Praxis Research Site

    Madrid, 28006, Spain

  • Praxis Research Site

    Madrid, 28010, Spain

  • Praxis Research Site

    Madrid, 28040, Spain

  • Praxis Research Site

    Málaga, 29010, Spain

  • Praxis Research Site

    Terrassa, 08222, Spain

  • Praxis Research Site

    Valencia, 46026, Spain

  • Praxis Research Site

    Phoenix, Arizona, 85032, United States

  • Praxis Research Site

    Loma Linda, California, 92345, United States

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