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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: GRIN-related Neurodevelopmental Disorder

In brief

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.

Key facts

Study ID

NCT07224581

Run by

GRIN Therapeutics, Inc.

People needed

100

Starts

2026-01-05

Expected to finish

2028-07-01

Last updated by the study team

2026-07-17

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Great Ormond Street Hospital For Children NHS Foundation Trust — London, United Kingdom (enrolling)
• Lucile Packard Children's Hospital — Palo Alto, California, United States (enrolling)
• Children's Hospital Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
• Pediatric Neurology and Epilepsy — Winter Park, Florida, United States (enrolling)
• Iowa Health Care - Pediatric Neurology & Specialty Clinic — Iowa City, Iowa, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Northeast Regional Epilepsy Group (NEREG) - Hackensack — Hackensack, New Jersey, United States (enrolling)
• Columbia University - Harkness — New York, New York, United States (enrolling)
• Duke Health-Duke Children's Hospital & Health Center — Durham, North Carolina, United States (enrolling)
• UCLA Health - Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Child Neurology Consultants of Austin - South Austin — Austin, Texas, United States (enrolling)
• The University of Texas Southwestern Medical Center (UTSW) — Dallas, Texas, United States (enrolling)
• UTHealth Houston — Houston, Texas, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• UZ Brussel — Brussels, Belgium (enrolling)
• Centre Hospitalier Universitaire d'Angers (CHU Angers) — Angers, France (enrolling)
• Hospices Civils De Lyon — Bron, France (enrolling)
• Hôpital Necker Enfants Malades — Paris, France (enrolling)
• CHU Toulouse - Hôpital Purpan — Toulouse, France (enrolling)
• Universitatsmedizin Greifswald Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe — Greifswald, Germany (enrolling)
• Klinik und Policlinik fur Kinder - und Jugendmedizin — Leipzig, Germany (enrolling)
• Azienda Ospedaliera Universitaria Meyer IRCCS — Florence, Viale Pieraccini, Italy (enrolling)

Full record on ClinicalTrials.gov

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