Back to search results

Beeline: A Study of Radiprodil for GRIN-related Neurodevelopmental Disorder

This study, called Beeline, is testing a medication called radiprodil oral suspension for people with GRIN-related neurodevelopmental disorder (GRIN-NDD). This condition is caused by specific changes in GRIN1, GRIN2A, GRIN2B, or GRIN2D genes. The study aims to see if radiprodil is safe and effective. It will enroll about 100 participants, aged 1 month to 18 years, who have a GRIN-NDD diagnosis with a "gain-of-function" genetic change. For some participants, success will be measured by a reduction in countable motor seizures (CMS) over 12 weeks. For others, the focus is on tracking side effects over 24 weeks or an average of 2 years. The study is currently unclear on its recruitment status.

Study design
This is a multinational, multicenter, randomized, double-blind, placebo-controlled study, meaning you have an equal chance of receiving radiprodil or a placebo (inactive substance). It includes an open-label extension where all participants can receive radiprodil.
What's involved
You would go through a screening period, then a 4-week period where the dose of radiprodil or placebo is gradually increased. After that, you would take the study medication for 12 or 24 weeks, followed by a tapering period. If you choose, you can continue to receive radiprodil in an open-label extension for an average of 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants who do not enter the open-label extension will have a follow-up period after tapering. Those in the open-label extension will have a follow-up observation period after leaving the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224581

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

Recruiting
PHASE3Ages 1–18InterventionalTreatment
GRIN Therapeutics, Inc.
~100 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:RadiprodilPlacebo

At a glance

Recruiting sites
33 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): Countable motor seizures (CMS)
Measured over 12 weeks
+2 more outcomes measured

Conditions

GRIN-related Neurodevelopmental Disorder

Explore related trials

Autosomal dominant intellectual disability, craniofacial dysmorphism, macrocephaly, hypotonia syndrome due to H1-4 mutationGLUTAMATE RECEPTOR, IONOTROPIC, N-METHYL-D-ASPARTATE, SUBUNIT 1GRIN2A GeneGRIN2B GeneGRIN2D Gene

NCT07224581

Where you'd take part

This study runs at 34 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, Viale Pieraccini, Italystudy coordinator listed

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire d'Angers (CHU Angers)

    Angers, Francestudy coordinator listed

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Children's National Hospital

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • CHU Toulouse - Hôpital Purpan

    Toulouse, Francestudy coordinator listed

    Recruiting

  • Columbia University - Harkness

    New York, New Yorkstudy coordinator listed

    Recruiting

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

    Durham, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephen Tisi · STUDY_DIRECTOR · GRIN Therapeutics, Inc.
  • Russell Chin · STUDY_DIRECTOR · GRIN Therapeutics, Inc.

Who to contact

Clinical Operations
[email protected]
+1-877-225-0014
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Part A - Phase 3 Cohort 1 (Qualifying Seizures Cohort): Countable motor seizures (CMS)12 weeks
  • Part A - Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort): Adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs)24 weeks
  • Part B - Open-Label Extension: Adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs)Average of 2 years