[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GRIN Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"GRIN-related Neurodevelopmental Disorder",[29,30,31,32,33,34],"Beeline","GRIN1","GRIN2A","GRIN2B","GRIN2D","GRIN-NDD","RECRUITING","2026-06-26",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2026-01-05",{"date":43,"type":21},"2028-07",{"name":45,"class":46},"GRIN Therapeutics, Inc.","INDUSTRY",33,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100628099","phase-1-radiprodil-in-participants-with-hepatic-impairment-100628099","NCT07457229","Radiprodil in Participants With Hepatic Impairment","Phase 1, Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Radiprodil in Hepatically Impaired Participants","Inclusion Criteria:\n\n* Male or female participants aged 18 to 75 years, inclusive, at Screening.\n* Body mass index (BMI) within the range specified in the protocol.\n* Participants with hepatic impairment must have stable mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment, as applicable to cohort assignment.\n* Healthy participants must be medically healthy with no clinically significant abnormalities as determined by the investigator.\n* Participants must be willing and able to comply with all study procedures and confinement requirements.\n* Participants of childbearing potential must agree to use highly effective contraception methods as defined in the protocol.\n* Participants must provide written informed consent prior to any study procedures\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical conditions that could interfere with study participation or interpretation of results.\n* Positive test for drugs of abuse, alcohol, or cotinine (where applicable) at Screening or check-in.\n* Positive serology for HIV, hepatitis B surface antigen, or hepatitis C virus.\n* Clinically significant abnormal laboratory values, vital signs, or ECG findings at Screening or Day -1, as judged by the investigator.\n* Use of prohibited concomitant medications or substances that may interfere with radiprodil metabolism.\n* Pregnant or breastfeeding women.\n* Participation in another clinical study or receipt of an investigational product within the protocol-specified timeframe prior to dosing.\n* Any condition that, in the opinion of the investigator or sponsor, would make participation not in the best interest of the participant or could confound study results.",true,"75 Years",{"count":58,"type":21},40,[60],"PHASE1","This Phase 1, open-label study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with healthy participants. Radiprodil is being developed as a potential treatment for GRIN-related neurodevelopmental disorders, tuberous sclerosis complex, and focal cortical dysplasia.\n\nApproximately 40 adults aged 18 to 75 years will be enrolled into five cohorts based on liver function (mild, moderate, or severe hepatic impairment) or healthy status. Participants will receive a single 15 mg oral dose of radiprodil and remain in the clinical research unit for intensive PK and safety monitoring through Day 6.\n\nThe primary objective is to characterize the PK profile of radiprodil in participants with hepatic impairment compared with healthy participants. Safety and tolerability will also be assessed. Results from this study will help determine whether dose adjustments are needed in individuals with impaired liver function.",[63],"Hepatic Impairment",[65,66],"Hepatic impairment","Radiprodil","2026-05-05",{"date":69,"type":39},"2026-05-08",{"date":71,"type":39},"2026-03-03",{"date":73,"type":21},"2027-08",{"name":45,"class":46},""]