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NCT07224581 · ClinicalTrials.gov registry record · Phase 3
Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder
A Phase 3 study of GRIN-related Neurodevelopmental Disorder, sponsored by GRIN Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 17
- Study locations
NCT07224581: Recruiting Phase 3 study of GRIN-related Neurodevelopmental Disorder, sponsored by GRIN Therapeutics.
NCT07224581 is a Phase 3 study of GRIN-related Neurodevelopmental Disorder that is actively recruiting participants, run by GRIN Therapeutics. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07224581, a Phase 3 study of GRIN-related Neurodevelopmental Disorder, is actively recruiting participants, sponsored by GRIN Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 17
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The listed sponsor is GRIN Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT07224581 reports 17 study locations spanning 13 distinct geographic areas - top geographies include Texas, California, Florida.
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.
What interventions are being tested in trial NCT07224581?
The interventions under investigation include: Placebo (DRUG), Radiprodil (DRUG).
Who is sponsoring clinical trial NCT07224581?
This trial is sponsored by GRIN Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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How this trial's enrollment target compares
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