A Multinational, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Participants with GRIN-related Neurodevelopmental Disorder in an Open-Label, Phase 1b Cohort and Two Randomized, Double-blind Cohorts, followed by an Open-label Extension
RAD-GRIN-101
What is the goal of the study?
This is a 1a-3b multinational, multicenter study. The study will evaluate the safety, tolerability, pharmacokinetics, and effect of Radiprodil on seizures and behavioral symptoms in participants with GRIN-related Neurodevelopmental Disorder. There are 2 parts to this study. Part A includes 1B which is an open label dose finding, pharmacokinetics and safety study followed by 2 Phase 3 double blind randomized cohorts. One of the cohorts will have seizures and one without seizures. The Phase 3 objective is to evaluate the change in seizure frequency and/or CNS features (including behavior, motor symptoms). Part B is an Open-Label Extension study. Our site will be enrolling in Part A, Phase 3 Randomized Qualifying Seizure Cohort or Randomized Auxiliary Cohort in Participants without Qualifying Seizures. Up to 60 participants from all sites will be randomized for the Phase 3 studies and will be stratified by ages ages 2 and younger, greater than 2-12 and 13 to adult.
Who can participate in the study?
Please contact the study team listed below to learn more.