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Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder
Sponsor: GRIN Therapeutics, Inc.
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.
Official title: A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Placebo-Controlled Phase 3 Followed by an Open-Label Extension to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Radiprodil in Participants With GRIN-Related Neurodevelopmental Disorder
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-01-05
Completion Date
2028-07
Last Updated
2026-06-29
Healthy Volunteers
No
Conditions
Interventions
Radiprodil
Radiprodil oral suspension
Placebo
Placebo-to-match radiprodil oral suspension
Locations (33)
UCLA Health - Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Children's Hospital Colorado - Anschutz Medical Campus
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Pediatric Neurology and Epilepsy
Winter Park, Florida, United States
Iowa Health Care - Pediatric Neurology & Specialty Clinic
Iowa City, Iowa, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Northeast Regional Epilepsy Group (NEREG) - Hackensack
Hackensack, New Jersey, United States
Columbia University - Harkness
New York, New York, United States
Duke Health-Duke Children's Hospital & Health Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Child Neurology Consultants of Austin - South Austin
Austin, Texas, United States
The University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas, United States
UTHealth Houston
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
UZ Brussel
Brussels, Belgium
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, France
Hospices Civils De Lyon
Bron, France
Hôpital Necker Enfants Malades
Paris, France
CHU Toulouse - Hôpital Purpan
Toulouse, France
Universitatsmedizin Greifswald Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe
Greifswald, Germany
Klinik und Policlinik fur Kinder - und Jugendmedizin
Leipzig, Germany
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Viale Pieraccini, Italy
IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia, Italy
Ospedale Pediatrico Bambino Gesu
Roma, Italy
Erasmus MC (Erasmus Universitair Medisch Centrum Rotterdam)
Rotterdam, South Holland, Netherlands
Institute of Polish Mother's Health Center (Instytut Centrum Zdrowia Matki Polki)
Lodz, Poland
University Children's Hospital
Ljubljana, Slovenia
Hospital Sant Joan de Deus
Esplugues de Llobregat, Barcelona, Spain
Sheffield Children's Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Royal Hospital for Children Glasgow
Glasgow, United Kingdom