Condition: GRIN-related Neurodevelopmental Disorder · Sponsor: GRIN Therapeutics, Inc.
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.
This description comes directly from the study's public registry record.
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Always discuss trial participation with your own doctor first.
| UCLA Health - Ronald Reagan UCLA Medical Center | Los Angeles, California, United States | Recruiting |
| Lucile Packard Children's Hospital | Palo Alto, California, United States | Recruiting |
| Children's Hospital Colorado - Anschutz Medical Campus | Aurora, Colorado, United States | Recruiting |
| Children's National Hospital | Washington D.C., District of Columbia, United States | Recruiting |
| Nicklaus Children's Hospital | Miami, Florida, United States | Recruiting |
| Pediatric Neurology and Epilepsy | Winter Park, Florida, United States | Recruiting |
| Iowa Health Care - Pediatric Neurology & Specialty Clinic | Iowa City, Iowa, United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Recruiting |
| Northeast Regional Epilepsy Group (NEREG) - Hackensack | Hackensack, New Jersey, United States | Recruiting |
| Columbia University - Harkness | New York, New York, United States | Recruiting |
| Duke Health-Duke Children's Hospital & Health Center | Durham, North Carolina, United States | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States | Not Yet Recruiting |
+ 22 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07224581