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GRIN-related Neurodevelopmental DisorderPhase 3NCT07224581

Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder

A Phase 3 study testing Radiprodil in people with GRIN-related Neurodevelopmental Disorder, run by GRIN Therapeutics, Inc. at 34 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The Phase 3 portion of Study RAD-GRIN-101 is a multinational, multicenter, randomized, double-blind, placebo-controlled trial followed by an open-label extension to evaluate the efficacy and safety of radiprodil in participants with GRIN-related neurodevelopmental disorder (GRIN-NDD) with a gain-of-function (GoF)… Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
GRIN-related Neurodevelopmental Disorder
What is being tested?
Radiprodil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
34 sitesin 10 countries
Study dates
5 Jan 2026to Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Clinical Operations contact

+1-877-225-0014

ClinicalTrials@GrinTherapeutics.com

34 sites in 10 countries

United States17 sites, 17 recruiting

  • Children's Hospital Colorado - Anschutz Medical Campus

    Aurora, Colorado, 80045

    Recruiting

  • Child Neurology Consultants of Austin - South Austin

    Austin, Texas, 78757

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Helen Olson, Helen.Olson@childrens.harvard.edu

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Not yet recruiting

  • The University of Texas Southwestern Medical Center (UTSW)

    Dallas, Texas, 75390

    Recruiting

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

    Durham, North Carolina, 27705

    Gloria Pinero, 919-613-0767, gloria.pinero@duke.edu

    Recruiting

  • Northeast Regional Epilepsy Group (NEREG) - Hackensack

    Hackensack, New Jersey, 07601

    Hardik A Rana, MBBS, 551-497-5000, hrana@epilepsygroup.com

    Recruiting

  • UTHealth Houston

    Houston, Texas, 77030

    Annette Frenk, MSc, 713-500-7164, Annette.C.FrenkOquendo@uth.tmc.edu

    Recruiting

  • Iowa Health Care - Pediatric Neurology & Specialty Clinic

    Iowa City, Iowa, 52242

    Recruiting

  • UCLA Health - Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Angela Martinez, 310-968-8942, AngelaMartinez@mednet.ucla.edu

    Recruiting

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

    Dainelys Pena Rodriquez, 786-624-3547, dainelys.penarodriguez@nicklaushealth.org

    Recruiting

  • Columbia University - Harkness

    New York, New York, 10032

    Jaimie Gowatsky, 917-838-6514, jg2917@cumc.columbia.edu

    Recruiting

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304

    650-721-1458

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Jennie Minnick, MINNICK@chop.edu

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Recruiting

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

    Chloe Hooker, 202-476-4809, chooker@childrensnational.org

    Recruiting

  • Pediatric Neurology and Epilepsy

    Winter Park, Florida, 32789

    Denise Hubert, 407-293-1122, dhubert@pediatricneurologyandepilepsy.com

    Recruiting

Other trials in United States

France4 sites, 4 recruiting

  • Centre Hospitalier Universitaire d'Angers (CHU Angers)

    Angers, 49933

    Patrick Van Bogaert, Patrick.VanBogaert@chu-angers.fr

    Patrick Van Bogaert

    Recruiting

  • Hospices Civils De Lyon

    Bron, 69677

    Eleni Panagiotakaki, eleni.panagiotakaki@chu-lyon.fr

    Lea Barbieri, lea.barbieri01@chu-lyon.fr

    Recruiting

  • Hôpital Necker Enfants Malades

    Paris, 75743

    Rima Nabbout, rima.nabbout@aphp.fr

    Michaela Semeraro, michaela.semeraro@aphp.fr

    Recruiting

  • CHU Toulouse - Hôpital Purpan

    Toulouse, Cedex 9

    Caroline Hachon Le Camus, hachonlecamus.c@chu-toulouse.fr

    Caroline Hachon Le Camus

    Recruiting

Other trials in France

Italy3 sites, 3 recruiting

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, Viale Pieraccini, 24

    Renzo Guerrini, r.guerrini@meyer.it

    Renzo Guerrini

    Recruiting

  • IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino

    Pavia

    Valentina De Giorgis, valentina.degiorgis@mondino.it

    Valentina De Giorgis

    Recruiting

  • Ospedale Pediatrico Bambino Gesu

    Roma, 00165

    Nicola Specchio, nicola.specchio@opbg.net

    Nicola Pietrafusa, nicola1.pietrafusa@opbg.net

    Recruiting

Other trials in Italy

United Kingdom3 sites, 3 recruiting

  • Royal Hospital for Children Glasgow

    Glasgow

    Sameer Zuberi, sameer.zuberi@ggc.scot.nhs.uk

    Sameer Zuberi

    Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, G51 4TF

    Amy McTague, MD, a.mctague@ucl.ac.uk

    Amy McTague, MD

    Recruiting

  • Sheffield Children's Hospital NHS Foundation Trust

    Sheffield, South Yorkshire

    Archana Desurkar, archana.desurkar@sch.nhs.uk

    Archana Desurkar

    Recruiting

Other trials in United Kingdom

Germany2 sites, 2 recruiting

  • Universitatsmedizin Greifswald Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe

    Greifswald

    Astrid Bertsche, astrid.bertsche@med.uni-greifswald.de

    Astrid Bertsche

    Recruiting

  • Klinik und Policlinik fur Kinder - und Jugendmedizin

    Leipzig, 04103

    Andreas Merkenschlager, Andreas.Merkenschlager@medizin.uni-leipzig.de

    Mb-Beeline@medizin.uni-leipzig.de

    Recruiting

Other trials in Germany

Belgium1 site, 1 recruiting

  • UZ Brussel

    Brussels, 1090

    Ine Hoogwijs, ine.hoogwijs@uzbrussel.be

    Yentse Caeyers, yentse.caeyers@uzbrussel.be

    Recruiting

Other trials in Belgium

Netherlands1 site, 1 recruiting

  • Erasmus MC (Erasmus Universitair Medisch Centrum Rotterdam)

    Rotterdam, South Holland

    Danielle Veenma, d.veenma@erasmusmc.nl

    Grin.encore@erasmusmc.nl

    Recruiting

Other trials in Netherlands

Poland1 site, 1 recruiting

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

    Lodz, 93-338

    Lukasz Przyslo, lukasz.przyslo@iczmp.edu.pl

    Lukasz Przyslo

    Recruiting

Other trials in Poland

Slovenia1 site, 1 recruiting

  • University Children's Hospital

    Ljubljana, 1525

    Damjan Osredkar, damjan.osredkar@kclj.si

    Nika Košir, nika.kosir@kclj.si

    Recruiting

Other trials in Slovenia

Spain1 site, 1 recruiting

  • Hospital Sant Joan de Deus

    Esplugues de Llobregat, Barcelona

    Angeles Garcia Cazorla, angeles.garcia@sjd.es

    Juan Lascano Nazareno, nazarenojuan.lascano@sjd.es

    Recruiting

Other trials in Spain

About this study

Official title: A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Placebo-Controlled Phase 3 Followed by an Open-Label Extension to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Radiprodil in Participants With GRIN-Related Neurodevelopmental Disorder

The Phase 3 portion of Study RAD-GRIN-101 is a multinational, multicenter, randomized, double-blind, placebo-controlled trial followed by an open-label extension to evaluate the efficacy and safety of radiprodil in participants with GRIN-related neurodevelopmental disorder (GRIN-NDD) with a gain-of-function (GoF) genetic variant.

This study will enroll two cohorts: one cohort of participants with a minimal number of countable motor seizures (with or without behavioral symptoms) (Phase 3 Cohort 1: Qualifying Seizures Cohort); and a second cohort with disease symptoms but no seizures or fewer seizures than required for the Qualifying Seizures Cohort (Phase 3 Cohort 2: Without Qualifying Seizures Auxiliary Cohort).

Read more

Participants in each cohort will be randomized 1:1 to receive active drug (radiprodil) or matching placebo (Part A). Following completion of Part A, all eligible participants (including those previously on placebo) may continue into the open-label extension period (Part B) to receive radiprodil.

The placebo-controlled portion is expected to be approximately 16 weeks for participants in Phase 3 Cohort 1 and 28 weeks for participants in Phase 3 Cohort 2.

The study will evaluate the effect of radiprodil on seizures and non-seizure symptoms and assess safety.

Read the detailed description

Participants are assigned in a 1:1 ratio to receive either radiprodil or placebo during Part A with the opportunity to receive radiprodil in the Open-Label Extension, Part B. The dosing regimen includes a fixed titration schedule over 4 weeks.

This study is divided into the following parts:

Part A: Randomized, double-blind, placebo-controlled

  • Screening/Observation Period: To assess eligibility
  • Titration Period (approximately 4 weeks): Titration of radiprodil or placebo to target dose
  • Maintenance Period (Part A): Target dose of radiprodil or placebo maintained for 12 weeks (Phase 3 Cohort 1) or 24 weeks (Phase 3 Cohort 2)
  • Tapering and Follow-up Period: Gradual decrease and Follow-up Period for participants not entering Part B

Part B: Open-label safety follow-up period

  • Open-Label Treatment Period: Participants will continue to receive radiprodil until such time as either the participant withdraws/is withdrawn from the study, sponsor terminates the study, or market access is available
  • Tapering and Follow-up Period: Gradual decrease and follow-up observation period for participants upon leaving the study
Being tested
Radiprodil, Placebo
Keywords
Beeline, GRIN1, GRIN2A, GRIN2B, GRIN2D, GRIN-NDD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiprodilDrug

    Radiprodil oral suspension

  • PlaceboDrug

    Placebo-to-match radiprodil oral suspension

Study groups in NCT07224581
Study groupRoleWhat they receive
RadiprodilExperimentalLiquid suspension of radiprodil, at varying concentrations depending on participant's weight. The following dose-escalation regimen (twice daily [BID]) will be used: Titration Period Visit 1 (Visit T1): Dose 1, Visit T2: Dose 2, Visit T3: Dose 3, Visit T4: Maintenance Dose.
Receives: Drug: Radiprodil
PlaceboPlacebo comparatorLiquid suspension of placebo matching radiprodil oral suspension and dose-escalation regimen.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): Countable motor seizures (CMS)

    Measured: 12 weeks

  2. Part A - Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort): Adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs)

    Measured: 24 weeks

  3. Part B - Open-Label Extension: Adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs)

    Measured: Average of 2 years

Secondary outcomes (13)

  1. Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): Proportion of participants with ≥50% reduction in CMS

    Measured: 12 weeks

  2. Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): CMS-free days

    Measured: 12 weeks

  3. Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): GRIN-NDD-specific Clinical Global Impression - Change [CGI-C] scale

    Measured: 12 weeks

  4. Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): Aberrant Behavior Checklist-Community (ABC-2C) irritability subscale

    Measured: 12 weeks

  5. Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): Vineland Adaptive Behavior Scale 3rd edition (VABS-3) daily living personal subdomain

    Measured: 12 weeks

  6. Part A - Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort): GRIN-CGI-C scale

    Measured: 24 weeks

  7. Part A - Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort): ABC-2C irritability subscale

    Measured: 24 weeks

  8. Part A - Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort): VABS-3 daily living personal subdomain

    Measured: 24 weeks

  9. PART B - Open-Label Extension: CMS frequency

    Measured: average of 2 years

  10. PART B - Open-Label Extension: CMS-free days

    Measured: average of 2 years

  11. PART B - Open-Label Extension: ABC-2C irritability subscale

    Measured: average of 2 years

  12. PART B - Open-Label Extension: VABS-3 daily living personal subdomain score

    Measured: average of 2 years

  13. PART B - Open-Label Extension: GRIN-CGI-C scale

    Measured: average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2025
  2. Study start5 Jan 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07224581
Sponsor's protocol ID
Beeline RAD-GRIN-101
Status last verified
Jul 2026
First submitted
31 Oct 2025
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiprodil in people with GRIN-related Neurodevelopmental Disorder, run by GRIN Therapeutics, Inc. at 34 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, France, Italy, United Kingdom, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Operations (+1-877-225-0014, ClinicalTrials@GrinTherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): Countable motor seizures (CMS) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07224581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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