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Promising new drug targets seizures in rare GRIN disorder

NCT ID NCT07224581

Disease control Sponsor: GRIN Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 4 times

Summary

This study tests a drug called radiprodil in people with GRIN-related neurodevelopmental disorder, a rare genetic condition that often causes seizures and developmental delays. The trial includes two groups: one with frequent seizures and one with fewer or no seizures. Participants are randomly assigned to receive radiprodil or a placebo for 16 to 28 weeks, followed by an open-label phase where everyone can get the active drug. The goal is to see if radiprodil reduces seizures and improves other symptoms safely.

What this could mean

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

Active substance
radiprodil
What this could lead to
If successful, radiprodil could become the first targeted treatment to reduce seizures and improve daily function in people with GRIN-related neurodevelopmental disorder.
What could go wrong
This is an early-stage Phase 3 trial with only 100 participants, so results may not apply to everyone. The drug may cause side effects or fail to show clear benefit over placebo.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

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

1 month to 18 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: Part A, Participant: * Diagnosed with GRIN-NDD with GRIN1, GRIN2A, GRIN2B, or GRIN2D gene variants known to result in GoF of the NMDA receptor * Phase 3 Cohort 1 (Qualifying Seizures Cohort) ONLY: Experiencing at least 1 CMS per week and ≥4 CMS (generalized or focal) during screening * With history of inadequate response to at least 2 standard antiseizure medications (ASMs) * Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort) ONLY: With significant neurodevelopmental symptoms and a GRIN-CGI-S score ≥4 * On a stable dose of standard ASMs for at least 4 weeks prior to screening and should remain on stable doses throughout study participation * On stable nonpharmacological treatments such as ketogenic diet and should remain stable throughout study participation Part B: \- Participant has completed Part A and is eligible to continue study participation according to the judgement of the investigator and sponsor. Exclusion Criteria: PART A, Participant: * Has clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder (including those related to GRIN-NDD) that would preclude or jeopardize participant's safe participation or study drug administration or the conduct of the study according to the judgement of the investigator or sponsor. * Is receiving \>4 standard ASMs at screening * Has a body weight of less than 5 kg at screening Part B: \- Participant has clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder (including those related to GRIN-NDD) that would preclude or jeopardize participant's safe participation of study drug administration or the conduct of the study according to the judgement of the investigator or sponsor.

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Conditions

The condition(s) this trial relates to.

GRIN-related complex neurodevelopmental disorder

As listed by the trial registrant

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

Grin-related neurodevelopmental disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    RECRUITING

    Florence, Viale Pieraccini, 24, Italy

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHU Toulouse - Hôpital Purpan

    RECRUITING

    Toulouse, Cedex 9, France

  • Centre Hospitalier Universitaire d'Angers (CHU Angers)

    RECRUITING

    Angers, 49933, France

  • Child Neurology Consultants of Austin - South Austin

    RECRUITING

    Austin, Texas, 78757, United States

  • Children's Hospital Colorado - Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Columbia University - Harkness

    RECRUITING

    New York, New York, 10032, United States

  • Duke Health-Duke Children's Hospital & Health Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Erasmus MC (Erasmus Universitair Medisch Centrum Rotterdam)

    RECRUITING

    Rotterdam, South Holland, Netherlands

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    RECRUITING

    London, G51 4TF, United Kingdom

  • Hospices Civils De Lyon

    RECRUITING

    Bron, 69677, France

  • Hospital Sant Joan de Deus

    RECRUITING

    Esplugues de Llobregat, Barcelona, Spain

  • Hôpital Necker Enfants Malades

    RECRUITING

    Paris, 75743, France

  • IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino

    RECRUITING

    Pavia, Italy

  • Institute of Polish Mother's Health Center (Instytut Centrum Zdrowia Matki Polki)

    RECRUITING

    Lodz, 93-338, Poland

  • Iowa Health Care - Pediatric Neurology & Specialty Clinic

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Klinik und Policlinik fur Kinder - und Jugendmedizin

    RECRUITING

    Leipzig, 04103, Germany

  • Lucile Packard Children's Hospital

    RECRUITING

    Palo Alto, California, 94304, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Northeast Regional Epilepsy Group (NEREG) - Hackensack

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Ospedale Pediatrico Bambino Gesu

    RECRUITING

    Roma, 00165, Italy

  • Pediatric Neurology and Epilepsy

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Royal Hospital for Children Glasgow

    RECRUITING

    Glasgow, United Kingdom

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Sheffield Children's Hospital NHS Foundation Trust

    RECRUITING

    Sheffield, South Yorkshire, United Kingdom

  • The University of Texas Southwestern Medical Center (UTSW)

    RECRUITING

    Dallas, Texas, 75390, United States

  • UCLA Health - Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UTHealth Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • UZ Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • Universitatsmedizin Greifswald Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe

    RECRUITING

    Greifswald, Germany

  • University Children's Hospital

    RECRUITING

    Ljubljana, 1525, Slovenia