Actively Recruiting
Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder
Led by GRIN Therapeutics, Inc. · Updated on 2026-02-27
100
Participants Needed
17
Research Sites
129 weeks
Total Duration
On this page
Sponsors
G
GRIN Therapeutics, Inc.
Lead Sponsor
A
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with GRIN-NDD with GRIN1, GRIN2A, GRIN2B, or GRIN2D gene variants causing gain-of-function of the NMDA receptor
- For Phase 3 Cohort 1: Experiencing at least 1 countable motor seizure per week and at least 4 countable motor seizures during screening
- History of inadequate response to at least 2 standard antiseizure medications
- For Phase 3 Cohort 2: Significant neurodevelopmental symptoms and a GRIN-CGI-S score of 4 or higher
- On stable doses of standard antiseizure medications for at least 4 weeks prior to screening and remain stable during participation
- On stable nonpharmacological treatments such as ketogenic diet and remain stable during participation
- For Part B: Completed Part A and deemed eligible to continue by investigator and sponsor
You will not qualify if you...
- Clinically relevant medical, neurologic, psychiatric condition, or behavioral disorder that would jeopardize safe participation or study drug administration
- Receiving more than 4 standard antiseizure medications at screening
- Body weight less than 5 kg at screening
- For Part B: Clinically relevant medical, neurologic, psychiatric condition, or behavioral disorder that would jeopardize safe participation or study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
UCLA Clinical & Translational Research Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
3
Children's Hospital Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
6
Pediatric Neurology and Epilepsy
Winter Park, Florida, United States, 32789
Actively Recruiting
7
Iowa Health Care - Pediatric Neurology & Specialty Clinic
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
Northeast Regional Epilepsy Group (NEREG) - Hackensack
Hackensack, New Jersey, United States, 07601
Actively Recruiting
10
Columbia University - Harkness
New York, New York, United States, 10032
Actively Recruiting
11
Duke Health-Duke Children's Hospital & Health Center
Durham, North Carolina, United States, 27705
Actively Recruiting
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
13
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
Child Neurology Consultants of Austin - South Austin
Austin, Texas, United States, 78757
Actively Recruiting
15
The University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas, United States, 75390
Not Yet Recruiting
16
UTHealth Houston
Houston, Texas, United States, 77030
Actively Recruiting
17
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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