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Glasgow","Glasgow",{"type":102,"coordinates":573},[574,575],-4.25763,55.86515,{"lat":575,"lon":574},[578,581],{"name":579,"role":89,"phone":11,"phoneExt":11,"email":580},"Sameer Zuberi","sameer.zuberi@ggc.scot.nhs.uk",{"name":579,"role":333,"phone":11,"phoneExt":11,"email":11},{"type":583,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[585],{"name":586,"class":6},"Aziende Chimiche Riunite Angelini Francesco S.p.A","100610207","phase-3-beeline-a-phase-3-study-in-grin-related-neurodevelopmental-disorder-100610207",false,"NCT07224581","Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder","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","Inclusion Criteria:\n\nPart A, Participant:\n\n* Diagnosed with GRIN-NDD with GRIN1, GRIN2A, GRIN2B, or GRIN2D gene variants known to result in GoF of the NMDA receptor\n* Phase 3 Cohort 1 (Qualifying Seizures Cohort) ONLY: Experiencing at least 1 CMS per week and ≥4 CMS (generalized or focal) during screening\n* With history of inadequate response to at least 2 standard antiseizure medications (ASMs)\n* Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort) ONLY: With significant neurodevelopmental symptoms and a GRIN-CGI-S score ≥4\n* On a stable dose of standard ASMs for at least 4 weeks prior to screening and should remain on stable doses throughout study participation\n* On stable nonpharmacological treatments such as ketogenic diet and should remain stable throughout study participation\n\nPart B:\n\n\\- Participant has completed Part A and is eligible to continue study participation according to the judgement of the investigator and sponsor.\n\nExclusion Criteria:\n\nPART A, Participant:\n\n* Has clinically relevant medical, neurologic, or psychiatric condition and\u002For behavioral disorder (including those related to GRIN-NDD) that would preclude or jeopardize participant's safe participation or study drug administration or the conduct of the study according to the judgement of the investigator or sponsor.\n* Is receiving \\>4 standard ASMs at screening\n* Has a body weight of less than 5 kg at screening\n\nPart B:\n\n\\- Participant has clinically relevant medical, neurologic, or psychiatric condition and\u002For behavioral disorder (including those related to GRIN-NDD) that would preclude or jeopardize participant's safe participation of study drug administration or the conduct of the study according to the judgement of the investigator or sponsor.","ALL","1 Month","18 Years",{"count":598,"type":599},100,"ESTIMATED","INTERVENTIONAL",[602],"PHASE3","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.\n\nThis 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).\n\nParticipants 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.\n\nThe 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.\n\nThe study will evaluate the effect of radiprodil on seizures and non-seizure symptoms and assess safety.",[605],"GRIN-related Neurodevelopmental Disorder",[607,608,609,610,611,612],"Beeline","GRIN1","GRIN2A","GRIN2B","GRIN2D","GRIN-NDD","2026-06-26",{"date":615,"type":616},"2026-06-29","ACTUAL",{"date":618,"type":616},"2026-01-05",{"date":620,"type":599},"2028-07",{"name":5,"class":6},33]