[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Southwest Autism Research & Resource Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100387284","transgenerational-metabolic-immune-biomarkers-of-neurological-and-neurodevelopmental-disorders-100387284",false,"NCT04322734","Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders","Inclusion Criteria (ASD):\n\n1. ASD, as defined by either a gold standard measure for ASD diagnosis, the Autism Diagnostic Observation Schedule (ADOS); the Autism Diagnostic Interview-Revised (ADI-R); and\u002For a comprehensive assessment that is consistent with ASD, in the opinion of the principal investigator. For those the PI believes a prospective diagnosis of ASD is warranted, a formal diagnostic assessment will be scheduled at screening.\n2. 0 years through 17 years 11 months of age\n\nInclusion Criteria (TD, MD, Epilepsy, Brain Tumor, Psychiatric)\n\n1\\. 0 years to 17 years 11 months of age\n\nExclusion Criteria (All):\n\n1. History of a significant adverse reaction to a prior blood draw\n2. In females of reproductive age, pregnancy or plans to become pregnant\n3. Any other historical event\u002Finformation that may, in the opinion of the PI, be a reason to exclude the child from participation.",true,"ALL","18 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and\u002For questionnaires. Other samples may be collected when appropriate.\n\nThis study is currently recruiting.\n\nThere is no cost for visits or study-related exams.",[24,25,26,27,28,29],"Autism Spectrum Disorder","Mitochondrial Pathology","Epilepsy","Brain Tumor","Psychiatric Disorder","Mitochondrial Diseases","RECRUITING","2026-04-22",{"date":33,"type":34},"2026-04-23","ACTUAL",{"date":36,"type":34},"2023-12-13",{"date":38,"type":20},"2028-12-31",{"name":40,"class":41},"Southwest Autism Research & Resource Center","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100367112","phase-2-treatment-of-social-and-language-deficits-with-leucovorin-for-young-children-with-autism-100367112","NCT04060030","Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism","Inclusion Criteria:\n\n1. 1\\. Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).\n2. Between 2 years 6 months and 5 years 2 months of age at baseline\n3. Folate Receptor Alpha Autoantibody Positive status\n4. Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language)\n5. English included in the languages in which the child is being raised\n6. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment, so fulfilling #1 and #4 fulfills this requirement.\n7. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period\n8. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry\n9. Has at least 4 month old expressive language ability as assessed by the MSEL Expressive Language Scale (i.e., Parent answers \"yes\" to \" Voluntary babbling (such as 'bu, bu, bu\")\" Question #7 on the MSEL Expressive Language Scale.\n10. Ability to attend to social stimulus and tolerate imaging procedures, as determined at the discretion of the investigator\n\nExclusion Criteria:\n\n1. Known FRAA status by clinically validated test performed outside of research studies.\n2. Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 6 below)\n3. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior\n4. Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)\n5. Severe prematurity (\\\u003C34 weeks gestation) as determined by medical history\n6. Current uncontrolled gastroesophageal reflux\n7. Current or history of liver or kidney disease as determined by medical history and safety labs\n8. Genetic syndromes\n9. Congenital brain malformations\n10. Epilepsy\n11. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data\n12. Significant negative reaction (i.e. fainting, vomiting, etc.) as a result of a previous blood draw.\n13. Failure to thrive or Body Mass Index \\\u003C 5%ile or \\\u003C5%ile for weight (male \\\u003C11.2kg; female \\\u003C10.8kg by CDC 2000 growth charts) at the time of the study.\n14. Concurrent treatment with drug that would significantly interact with l-leucovorin such as specific chemotherapy agents, antimalarial and immune suppressive agents and select antibiotics (See Table 7 below).\n15. Allergy or Sensitivity to ingredients in the investigational product or placebo\n16. Evaluation with the MSEL or BOSCC within 3 months of entering the study\n17. Planned evaluation with the MSEL or BOSCC during the study\n18. Exclusion Criteria for the MEG recording include:\n\n    1. Ferromagnetic implants, artificial joints, fixation hardware, dental work or shrapnel (additional screening will be completed to determine MRI eligibility)\n    2. Ferromagnetic products attached to the body (including hair extensions)\n    3. Head circumference greater than 60 cm\n    4. A weight greater than 407 lbs. (185 kg)","30 Months","60 Months",{"count":52,"type":20},80,"INTERVENTIONAL",[55],"PHASE2","The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves social communication as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment.",[24,58],"Language Disorders",{"date":60,"type":34},"2026-04-27",{"date":62,"type":34},"2020-10-08",{"date":64,"type":20},"2026-07-31",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":53,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100556523","phase-2-investigating-a-marijuana-based-compound-as-a-treatment-for-anxiety-in-autistic-adults-100556523","NCT06526208","Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults","Phase 2 Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of an Oral Marijuana-Based Investigational Medical Product to Treat Anxiety in Adults With Autism Spectrum Disorder (ASD)","Inclusion Criteria:\n\n1. Male or female age 18 to 45 years old with an autism diagnosis.\n2. Participant is ≥ 100 lbs.\n3. Participant or a legally authorized representative provides informed consent\u002Fassent for participation in the trial.\n4. Participant\u002Fcaregiver is willing and able to comply with all study procedures.\n5. Participant meets ADOS-2 criteria for Autism or Autism Spectrum\n6. Participant meets DSM-5 criteria for ASD.\n7. Participant has a minimum CGI-S (Anxiety) score ≥ 5 based on anxiety related social functional impairment.\n8. Participant has a FSIQ ≥ 65 at screening measured with the WASI- II, or within 1 year of screening with a comparable assessment.\n9. Participant must have a negative pregnancy test (urine and serum) at Screening, and a negative urine test at Baseline, Active Phase Visits, and EoS visits, see Table 1. Schedule of Activities.\n10. Sexually active participants agree to use two methods of effective birth control, as described in Appendix B: Contraceptive and Barrier Guidance during the study intervention period and for at least 14 days after the Study Termination visit.\n11. Participant must be stable on any pre-study medications and\u002For psychotherapy for 6-weeks prior to study enrollment, agree to inform prescribing clinician(s) about participation in the study, and agree to maintain medication or psychotherapy treatment regimen during the study.\n12. Participant must be able to ingest MB-IMP (or placebo) and be willing to commit to medication dosing and completing the dosing diary.\n13. Participant\u002Fcaregiver agrees to keep all study medication provided by site staff securely stored at home and not to share\u002Fdistribute study medication to any other individual.\n14. Participant agrees not to participate in any other interventional clinical trials during the study period.\n15. Participant agrees to inform the investigators within 48- hours of any side-effects, medical conditions, and procedures.\n16. Participant agrees to abstain from alcohol use during the study.\n\nExclusion Criteria:\n\n1. Participant weighs \\< 100 lbs.\n2. Participant is sexually active and does not practice two effective forms of birth control.\n3. Participant is pregnant, lactating, or planning pregnancy during the study period or within 12 weeks thereafter.\n4. Participant has a current or historical psychotic features\u002Fdisorder assessed via the Mini-International Neuropsychiatric Interview (MINI).\n5. Participant has a current or historical DSM-5 diagnosis of dissociative identity disorder, positive family history (first-degree relative) of psychotic disorder or bipolar disorder type 1.\n6. At high risk of suicide or suicide attempts.\n\n   1. Individuals presenting current serious suicide risk, as determined through psychiatric interview, responses to the Columbia Suicide Severity Rating Scale (C-SSRS), and\u002For clinical judgment of the investigator.\n   2. History of suicide attempts within 12 months prior to study enrollment.\n7. Participant has a current substance use disorder within the 12 months prior to enrollment as determined by the MINI Kid56.\n8. Participant's urine drug screen is positive for opiates, methamphetamine, cocaine, THC, and amphetamines (unless prescribed). Participants with positive THC urine analysis tests are excluded from the study but will be allowed to rescreen (maximum twice) after a 1-month cessation of cannabis use.\n9. Participant has a history of arrhythmia, other than occasional premature atrial contractions (PACs) and premature ventricular contractions (PVCs) without ischemic heart disease, within 12 months of screening.\n10. Participant with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia, or any other arrhythmia associated with a bypass tract, may be enrolled only if they have been successfully treated with ablation and have not had a recurrent arrhythmia for at least one year off all antiarrhythmic drugs or are under adequate and stable pharmacologic treatment for atrial fibrillation for at least a year, as confirmed by a cardiologist.\n11. Participant has a current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, immunocompromising, or neurological disease according to PI's discretion.\n12. Evidence of existing hepatocellular injury defined as alanine transaminase (ALT) and aspertate aminotranferase (AST) elevations of greater than 3 times upper limit normal (ULN) and bilirubin elevation of greater than 2 times ULN.\n13. The PI or medical monitor deems the participant inappropriate for the study for any reason.\n14. Any known allergies\u002Fsensitivities to cannabis (in the opinion of the investigator).\n15. Not able to attend required face-to-face visits or those who plan to move out of the area within the treatment period.","45 Years",{"count":75,"type":20},108,[55],"The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are:\n\nWill a marijuana-based drug help anxiety in autistic adults?\n\nAnxiety can make socializing and working more difficult for people. Researchers will compare a marijuana based drug (that is mostly CBD with a small amount of THC) to a placebo (a look-alike substance that contains no drug) to see if the drug makes symptoms of anxiety better.\n\nParticipants will take the drug (or a placebo) every day for 8 weeks and keep a diary to record the time they took the drug, and their feelings each day. The drug is taken orally in drops once or twice a day. The study staff will speak to the participants weekly either over the phone or in the clinic. Clinic visits once every 2 weeks for checkups and tests. The researchers will make sure participants are healthy and see if there are any changes in anxiety.",[24,79],"Anxiety",[81,79,82,83,84,85],"Autism","marijuana","cannabis","CBD","THC","2026-03-24",{"date":88,"type":34},"2026-03-30",{"date":90,"type":34},"2025-05-28",{"date":92,"type":20},"2027-09-30",{"name":40,"class":41},1,""]