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RecruitingPhase 3

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

GRIN Therapeutics, Inc. · with Aziende Chimiche Riunite Angelini Francesco S.p.A · NCT07224581

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1 mo–18 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
100
US sites recruiting
16
Study start
January 5, 2026
Record last updated
July 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

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.

Being studied: Radiprodil; Placebo

Conditions: GRIN-related Neurodevelopmental Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • UCLA Health - Ronald Reagan UCLA Medical Center

    Los Angeles, CA 90095

    Site contact: Angela Martinez · 310-968-8942 · AngelaMartinez@mednet.ucla.edu

  • Lucile Packard Children's Hospital

    Palo Alto, CA 94304

    Site contact: 650-721-1458

  • Children's Hospital Colorado - Anschutz Medical Campus

    Aurora, CO 80045

  • Children's National Hospital

    Washington D.C., DC 20010

    Site contact: Chloe Hooker · 202-476-4809 · chooker@childrensnational.org

  • Nicklaus Children's Hospital

    Miami, FL 33155

    Site contact: Dainelys Pena Rodriquez · 786-624-3547 · dainelys.penarodriguez@nicklaushealth.org

  • Pediatric Neurology and Epilepsy

    Winter Park, FL 32789

    Site contact: Denise Hubert · 407-293-1122 · dhubert@pediatricneurologyandepilepsy.com

  • Iowa Health Care - Pediatric Neurology & Specialty Clinic

    Iowa City, IA 52242

  • Boston Children's Hospital

    Boston, MA 02115

    Site contact: Helen Olson · Helen.Olson@childrens.harvard.edu

  • Northeast Regional Epilepsy Group (NEREG) - Hackensack

    Hackensack, NJ 07601

    Site contact: Hardik A Rana, MBBS · 551-497-5000 · hrana@epilepsygroup.com

  • Columbia University - Harkness

    New York, NY 10032

    Site contact: Jaimie Gowatsky · 917-838-6514 · jg2917@cumc.columbia.edu

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

    Durham, NC 27705

    Site contact: Gloria Pinero · 919-613-0767 · gloria.pinero@duke.edu

  • Children's Hospital of Philadelphia

    Philadelphia, PA 19104

    Site contact: Jennie Minnick · MINNICK@chop.edu

  • Child Neurology Consultants of Austin - South Austin

    Austin, TX 78757

  • The University of Texas Southwestern Medical Center (UTSW)

    Dallas, TX 75390

  • UTHealth Houston

    Houston, TX 77030

    Site contact: Annette Frenk, MSc · 713-500-7164 · Annette.C.FrenkOquendo@uth.tmc.edu

  • Seattle Children's Hospital

    Seattle, WA 98105

Study contacts (from the official record)

  • Clinical Operations · +1-877-225-0014 · ClinicalTrials@GrinTherapeutics.com