U.S., Nov. 5 -- ClinicalTrials.gov registry received information related to the study (NCT07224581) titled 'Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder' on Oct. 31.
Brief 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...