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Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder
NCT07224581 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Radiprodil
Study Locations (17)
Texas
- Child Neurology Consultants of Austin - South Austin — Austin
- The University of Texas Southwestern Medical Center (UTSW) — Dallas
- UTHealth Houston — Houston
California
- UCLA Clinical & Translational Research Center — Los Angeles
- Lucile Packard Children's Hospital — Palo Alto
Florida
- Nicklaus Children's Hospital — Miami
- Pediatric Neurology and Epilepsy — Winter Park
Colorado
- Children's Hospital Colorado - Anschutz Medical Campus — Aurora
District of Columbia
- Children's National Hospital — Washington D.C.
Iowa
- Iowa Health Care - Pediatric Neurology & Specialty Clinic — Iowa City
Massachusetts
- Boston Children's Hospital — Boston
New Jersey
- Northeast Regional Epilepsy Group (NEREG) - Hackensack — Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-01-05 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07224581
The ClinicalTrials.gov registry entry for NCT07224581 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GRIN Therapeutics, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with GRIN-related Neurodevelopmental Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07224581 reports 17 study locations spanning 13 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07224581 about?
NCT07224581 is a clinical study titled "Beeline: A Phase 3 Study in 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-...
What is the current status of trial NCT07224581?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2026-01-05. Estimated completion is 2028-07.
What conditions does trial NCT07224581 study?
This clinical trial studies the following conditions: GRIN-related Neurodevelopmental Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07224581?
The interventions under investigation include: Placebo (DRUG), Radiprodil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07224581?
This trial is sponsored by GRIN Therapeutics, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07224581 being conducted?
This trial has 17 study locations across California, Colorado, District of Columbia, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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