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RecruitingNCT07224581Updated Jul 17, 2026

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

A Phase 3 interventional study of Radiprodil and Placebo in GRIN-related Neurodevelopmental Disorder, sponsored by GRIN Therapeutics, Inc.. Recruiting at 34 sites in 10 countries. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by GRIN Therapeutics, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Month to 18 Years
Sex
All
01

Study 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) 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.

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
02

Conditions studied

  • GRIN-related Neurodevelopmental Disorder

Keywords

  • Beeline
  • GRIN1
  • GRIN2A
  • GRIN2B
  • GRIN2D
  • GRIN-NDD
03

In context

Neurodevelopmental Disorders

352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.

This study's planned enrollment of 100 is above the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.

Browse Neurodevelopmental Disorders studies →

Lead sponsor

GRIN Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

PART A, Participant:

  • Has 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Radiprodil

    Liquid 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.

    Drug: Radiprodil

  • Placebo comparator
    Placebo

    Liquid suspension of placebo matching radiprodil oral suspension and dose-escalation regimen.

    Drug: Placebo

Interventions

  • DrugRadiprodil

    Radiprodil oral suspension

  • DrugPlacebo

    Placebo-to-match radiprodil oral suspension

06

What researchers measure

Primary outcomes

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

    Time frame: 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)

    Time frame: 24 weeks

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

    Time frame: Average of 2 years

Secondary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: average of 2 years

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

    Time frame: average of 2 years

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

    Time frame: average of 2 years

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

    Time frame: average of 2 years

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

    Time frame: average of 2 years

07

Study locations

33 of 34 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07224581
Lead sponsor
GRIN Therapeutics, Inc.
Collaborators
Aziende Chimiche Riunite Angelini Francesco S.p.A
Responsible party
Sponsor
First posted
Nov 4, 2025
Start date
Jan 5, 2026
Primary completion
May 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Jul 17, 2026

Study contacts

Clinical Operations
Contact
ClinicalTrials@GrinTherapeutics.com
+1-877-225-0014
Stephen Tisi
study director · GRIN Therapeutics, Inc.
Russell Chin
study director · GRIN Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Radiprodil

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