[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05889273":3,"trial-entities:NCT05889273":245,"trial-summary:NCT05889273":248},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":41,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":70,"locations":73,"central_contacts":238,"overall_officials":239,"references":240,"see_also_links":241},"NCT05889273","ML-004-003","ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)","An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).","ACTIVE_NOT_RECRUITING","2027-12","2026-03","2026-07-20","2023-06-01","MapLight Therapeutics","INDUSTRY",true,"ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.",null,[19],"Autism Spectrum Disorder",[21,22,19,23],"ASD","Autism","Social Communication","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},120,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","ML-004 (IR)\u002F(ER) tablet","Participants will receive ML-004 once daily.",[34],[38],{"measure":39,"timeFrame":40},"Frequency of occurrence of treatment-emergent adverse events (TEAEs).","Baseline up to Day 362",[42,44,46,48],{"measure":43,"timeFrame":40},"Frequency of occurrence of Serious Adverse Events (SAEs)",{"measure":45,"timeFrame":40},"Frequency of occurrence of TEAEs leading to discontinuation.",{"measure":47,"timeFrame":40},"Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments.",{"measure":49,"timeFrame":40},"Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale.","ALL","12 Years","46 Years",false,{"inclusion":55,"exclusion":63,"raw_text":69},[56,57,58,59,60,61,62],"Has completed Study ML-004-002 within the past 90 days","Age 12 years to 46 years at screening","Has a designated care\u002Fstudy partner who can reliably report on symptoms","Has a diagnosis of Autism Spectrum Disorder (ASD)","Has a body mass index (BMI) ≥18 kg\u002Fm²","Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening","Must be able to swallow study medication",[64,65,66,67,68],"Has Rett syndrome or Child Disintegrative Disorder","History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening","Has a positive response to C-SSRS questions 4 and\u002For 5, or is a significant risk for suicidal behavior","Has a clinical history of uncontrolled or severe hypertension","If female, is pregnant or lactating","Inclusion Criteria:\n\n* Has completed Study ML-004-002 within the past 90 days\n* Age 12 years to 46 years at screening\n* Has a designated care\u002Fstudy partner who can reliably report on symptoms\n* Has a diagnosis of Autism Spectrum Disorder (ASD)\n* Has a body mass index (BMI) ≥18 kg\u002Fm²\n* Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening\n* Must be able to swallow study medication\n\nExclusion Criteria:\n\n* Has Rett syndrome or Child Disintegrative Disorder\n* History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening\n* Has a positive response to C-SSRS questions 4 and\u002For 5, or is a significant risk for suicidal behavior\n* Has a clinical history of uncontrolled or severe hypertension\n* If female, is pregnant or lactating",[71,72],"CHILD","ADULT",[74,83,91,99,106,113,121,129,137,144,151,159,167,175,182,190,198,205,212,221,229],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Harmonex Neuroscience Research","Dothan","Alabama","36303","United States",{"lat":81,"lon":82},31.22323,-85.39049,{"facility":84,"city":85,"state":86,"zip":87,"country":79,"geoPoint":88},"Southwest Autism Research and Resource Center","Phoenix","Arizona","85006",{"lat":89,"lon":90},33.44838,-112.07404,{"facility":92,"city":93,"state":94,"zip":95,"country":79,"geoPoint":96},"Cortica Healthcare","Glendale","California","91203",{"lat":97,"lon":98},34.14251,-118.25508,{"facility":100,"city":101,"state":94,"zip":102,"country":79,"geoPoint":103},"NRC Research Institute","Orange","92868",{"lat":104,"lon":105},33.78779,-117.85311,{"facility":107,"city":108,"state":94,"zip":109,"country":79,"geoPoint":110},"Cortica","San Rafael","94903",{"lat":111,"lon":112},37.97353,-122.53109,{"facility":114,"city":115,"state":116,"zip":117,"country":79,"geoPoint":118},"Yale Child Study Center","New Haven","Connecticut","06519",{"lat":119,"lon":120},41.30815,-72.92816,{"facility":122,"city":123,"state":124,"zip":125,"country":79,"geoPoint":126},"The Children's Research Institute","Washington D.C.","District of Columbia","20010",{"lat":127,"lon":128},38.89511,-77.03637,{"facility":130,"city":131,"state":132,"zip":133,"country":79,"geoPoint":134},"Abba Medical Group","Miami","Florida","33176",{"lat":135,"lon":136},25.77427,-80.19366,{"facility":138,"city":139,"state":132,"zip":140,"country":79,"geoPoint":141},"APG Research, LLC","Orlando","32803",{"lat":142,"lon":143},28.53834,-81.37924,{"facility":145,"city":146,"state":132,"zip":147,"country":79,"geoPoint":148},"University of South Florida Psychiatry and Behavioral Neurosciences","Tampa","33613",{"lat":149,"lon":150},27.94752,-82.45843,{"facility":152,"city":153,"state":154,"zip":155,"country":79,"geoPoint":156},"Neurobehavioral Medicine Group","Bloomfield Hills","Michigan","48302",{"lat":157,"lon":158},42.58364,-83.24549,{"facility":160,"city":161,"state":162,"zip":163,"country":79,"geoPoint":164},"University of Missouri, Thompson Center for Autism & Neurodevelopment","Columbia","Missouri","65211",{"lat":165,"lon":166},38.95171,-92.33407,{"facility":168,"city":169,"state":170,"zip":171,"country":79,"geoPoint":172},"Nathan Kline Institute for Psychiatric Research","Orangeburg","New York","10962",{"lat":173,"lon":174},41.04649,-73.94958,{"facility":176,"city":177,"state":170,"zip":178,"country":79,"geoPoint":179},"Richmond Behavioral Associates","Staten Island","10314",{"lat":180,"lon":181},40.56233,-74.13986,{"facility":183,"city":184,"state":185,"zip":186,"country":79,"geoPoint":187},"Suburban Research Associates","Media","Pennsylvania","19063",{"lat":188,"lon":189},39.91678,-75.38769,{"facility":191,"city":192,"state":193,"zip":194,"country":79,"geoPoint":195},"BioBehavioral Research of Austin","Austin","Texas","78759",{"lat":196,"lon":197},30.26715,-97.74306,{"facility":199,"city":200,"state":193,"zip":201,"country":79,"geoPoint":202},"Road Runner Research, Ltd.","San Antonio","78249",{"lat":203,"lon":204},29.42412,-98.49363,{"facility":206,"city":207,"state":193,"zip":208,"country":79,"geoPoint":209},"Family Psychiatry of The Woodlands","The Woodlands","77381",{"lat":210,"lon":211},30.15799,-95.48938,{"facility":213,"city":214,"state":215,"zip":216,"country":217,"geoPoint":218},"Brain and Mind Centre","Camperdown","New South Wales","2050","Australia",{"lat":219,"lon":220},-33.88965,151.17642,{"facility":222,"city":223,"state":224,"zip":225,"country":217,"geoPoint":226},"The Royal Children's Hospital, Murdoch Children's Research Institute","Parkville","Victoria","3052",{"lat":227,"lon":228},-37.78333,144.95,{"facility":230,"city":231,"state":232,"zip":233,"country":234,"geoPoint":235},"Holland Bloorview Kids Rehabilitation Hospital","Toronto","Ontario","M4G 1R8","Canada",{"lat":236,"lon":237},43.70643,-79.39864,[],[],[],[242],{"label":243,"url":244},"ML-004-002","https:\u002F\u002Fclinicaltrials.gov\u002Fct2\u002Fshow\u002FNCT05081245?term=ML-004&draw=2&rank=1",{"nct_id":4,"conditions":246,"biomarkers":247},[19],[],{"nct_id":4,"found":53,"summary":17,"prompt_version":17}]