[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641213":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":32,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Shaare Zedek Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Folinic Acid","ACTIVE_COMPARATOR","Participants receive oral folinic acid (calcium folinate hydrate) oral solution as an add-on to their existing treatments. During the initial 9-week double-blind phase, participants receive folinic acid at a target dose of 2 mg\u002Fkg\u002Fday (maximum 50 mg\u002Fday) administered in two divided doses following a brief dose-titration period. After completion of the first phase, participants are independently randomized to receive folinic acid at either 1 mg\u002Fkg\u002Fday or 2 mg\u002Fkg\u002Fday for an additional 8 weeks while remaining blinded to dose assignment.",[13],"Drug: Folinic Acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive a matching placebo oral solution as an add-on to their existing treatments during the initial 9-week double-blind phase. After completion of the placebo-controlled phase, participants are independently randomized to receive folinic acid at either 1 mg\u002Fkg\u002Fday or 2 mg\u002Fkg\u002Fday for an additional 8 weeks while remaining blinded to dose assignment.",[19],"Drug: Placebo",[21,29],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Calcium folinate hydrate oral solution administered at a target dose of 2 mg\u002Fkg\u002Fday (maximum 50 mg\u002Fday) in two divided doses.",[9],[26,27,28],"Leucovorin","Calcium Folinate","Leucovorin Calcium",{"type":22,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Matching oral placebo solution containing inactive aqueous excipients and matched in appearance, taste, and smell to the folinic acid formulation",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Adi Aran, MD","CONTACT","+97226555414","aaran@szmc.org.il",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Jerusalem","N\u002FA = Not Applicable","9103102","Israel","IL",{"type":48,"coordinates":49},"Point",[50,51],35.21633,31.76904,{"lat":51,"lon":50},[54,57],{"name":55,"role":36,"phone":37,"phoneExt":32,"email":56},"Shahar Feller","folinics@gmail.com",{"name":35,"role":58,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Prof. Adi Aran","Director neuropediatric unit","100641213","phase-2-a-placebo-controlled-trial-of-folinic-acid-in-children-with-asd-100641213",false,"NCT07642661","A Placebo-controlled Trial of Folinic Acid in Children With ASD","A Placebo-Controlled, Randomized, Double-Blind Study to Assess the Safety, Tolerability and Efficacy of Folinic Acid Administered to Pediatric Subjects With Autism Spectrum Disorder (ASD)","AFAT","Inclusion Criteria:\n\n* Children aged 3 to 6 years.\n* Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria.\n* ASD diagnosis confirmed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).\n* ASD diagnosis made at least 6 months before screening.\n* Non-syndromic ASD, defined as ASD occurring in the absence of a known genetic syndrome, chromosomal abnormality, major congenital anomaly, or identifiable metabolic or neurological disorder.\n* CGI-S score ≥ 4.\n* ABC-I score ≥ 12.\n* SRS-2 total T-score ≥ 66.\n* Body weight between 11.45 kg and \\\u003C27 kg.\n\nExclusion Criteria:\n\n* A seizure or a change in antiepileptic medication within 8 weeks prior to randomization.\n* Clinically significant abnormalities on physical examination or laboratory testing, including significant impairment of cardiac, hepatic, or renal function.\n* Treatment with folinic acid within 3 months prior to randomization.\n* Any change in pharmacological treatment, behavioral treatment, home environment, or school setting (other than school holidays) within 4 weeks prior to randomization, or planned changes during study participation.\n* Predicted inability or unwillingness to comply with study procedures.\n* Use of antifolate medications or other agents known to interfere with folate metabolism (e.g., methotrexate, trimethoprim).","ALL","3 Years","6 Years",{"count":75,"type":76},150,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social communication and the presence of restricted or repetitive behaviors. Although behavioral and educational interventions can be helpful, there is currently no established medication for the core symptoms of ASD. Medications approved for associated irritability may be effective in some children but are often associated with significant adverse effects.\n\nFolinic acid (also known as leucovorin) is a reduced form of folate that plays an important role in brain development, neurotransmitter production, DNA methylation, and cellular metabolism. Previous clinical studies have suggested that folinic acid may improve communication, social functioning, and behavioral symptoms in some children with ASD. However, existing studies have generally been small and have used different outcome measures, and the current evidence is insufficient to establish the efficacy and optimal dosing of folinic acid in ASD.\n\nThis multicenter, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability, and efficacy of folinic acid in children with ASD. A total of 150 children aged 3 to 6 years with ASD and clinically significant behavioral symptoms will be enrolled at multiple sites in Israel. Participants will be randomly assigned in a 1:1 ratio to receive either folinic acid or matching placebo for 9 weeks in addition to their existing treatments.\n\nThe primary objective of the study is to determine whether folinic acid improves behavioral symptoms compared with placebo, as measured by the Aberrant Behavior Checklist Irritability Subscale (ABC-I). Secondary objectives include evaluating the effects of folinic acid on communication, socialization, adaptive functioning, autism symptoms, emotional regulation, disruptive behavior, sleep, gastrointestinal symptoms, caregiver quality of life, and overall clinical improvement.\n\nFollowing completion of the initial 9-week placebo-controlled phase, participants will enter a second 8-week double-blind treatment phase in which they will be randomly assigned to receive one of two folinic acid dose regimens. This phase is intended to explore whether different maintenance doses are associated with differences in clinical outcomes.\n\nThe study will also investigate potential biological markers associated with treatment response. Blood and stool samples will be collected to assess folate-related biomarkers, folate receptor alpha autoantibodies, oxidative stress markers, transcriptomic profiles, proteomic signatures, and gut microbiota composition. The study will also examine whether these biological measures are associated with symptom severity or response to treatment.\n\nThe results of this study are expected to provide important information regarding the efficacy, safety, and optimal use of folinic acid in children with ASD and may help identify biological factors associated with treatment response.",[82],"Autism Spectrum Disorder",[84,85,9,26,27,86,87],"ASD","Autism","placebo","Folate Receptor Alpha Autoantibodies","2026-06-17",{"date":90,"type":91},"2026-06-22","ACTUAL",{"date":93,"type":76},"2026-06-23",{"date":95,"type":76},"2027-12-31",{"name":61,"class":6},1]