[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608258":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":34,"locations":43,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Bazelet Nehushtan LtD.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Terpenes-Enriched CBD-Predominant Oil","EXPERIMENTAL","Oral cannabidiol (CBD), tetrahydrocannabinol (THC; 1\u002F28 of the CBD dose), and terpenes, administered for 8 weeks as an add-on to existing treatments. After the first 8 weeks, participants will continue with the same treatment for an additional 8 weeks.",[13],"Drug: Terpenes-Enriched CBD-Predominant Oil",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Oral olive oil with flavoring to mimic the texture and taste of the study drug, given for 8 weeks. After the first 8 weeks, participants will switch to terpenes-enriched CBD oil without THC for another 8 weeks.",[19,20],"Drug: Placebo","Drug: Terpenes-Enriched CBD Oil (THC-Free)",[22,27,30],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oral cannabidiol (CBD; 7.2 mg\u002Fkg\u002Fday), tetrahydrocannabinol (THC; 0.257 mg\u002Fkg\u002Fday, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg\u002Fkg\u002Fday), administered in two daily doses. The formulation is an olive oil-based solution (CBD\u002FTHC: 280\u002F10 mg per g) produced by Bazelet Group, Israel.",[9],null,{"type":23,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Oral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses.",[15],{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":26},"Terpenes-Enriched CBD Oil (THC-Free)","Oral cannabidiol (CBD; 7.2 mg\u002Fkg\u002Fday) and terpenes (0.5 mg\u002Fkg\u002Fday), administered in two daily doses. The formulation is an olive oil-based solution (CBD- 280 mg per g) produced by Bazelet Group, Israel.",[15],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Adi Aran, MD","CONTACT","+97226555414","aaran@szmc.org.il",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Daniel Korenfine","danielko@szmc.org.il",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Shaare Zedek Medical Center","RECRUITING","Jerusalem","N\u002FA = Not Applicable","9640610","Israel","IL",{"type":53,"coordinates":54},"Point",[55,56],35.21633,31.76904,{"lat":56,"lon":55},[59,61,63],{"name":36,"role":37,"phone":60,"phoneExt":26,"email":39},"0508685034",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":62},"danielko@szmc.co.il",{"name":36,"role":64,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":45,"oldNameTitle":26,"oldOrganization":26},"Adi Aran","Director, Neuropediatric unit, SZMC","100608258","phase-2-placebo-controlled-study-of-terpenes-enriched-cannabis-oil-t1c28-for-children-with-autism-100608258",false,"NCT07199218","Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1\u002FC28 for Children With Autism","A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study to Assess the Safety, Tolerability and Efficacy of Terpenes-enriched Cannabis Oil T1\u002FC28, Administered to Pediatric Subjects With Autism Spectrum Disorder (ASD)","TECA","Inclusion Criteria:\n\n1. Children aged 4 to 12 years (after the 4th birthday and before the 13th).\n2. Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2).\n3. Moderate or greater ASD-associated symptoms, defined as a rating of ≥4 (\"moderate\" or higher) on the Overall Function Clinical Global Impression-Severity (CGI-S).\n4. Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18.\n5. Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66.\n\nExclusion Criteria:\n\n1. Body weight \\\u003C12.5 kg or ≥57.5 kg.\n2. Current or past diagnosis of heart failure, drug addiction, schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder (PTSD), or major depressive disorder (MDD), or diagnosis of schizophrenia in a first-degree relative.\n3. Seizure or change in antiepileptic medications within 4 months prior to randomization.\n4. Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.\n5. Change in pharmacological or behavioral treatment, or change in home or school environment (other than school holidays), within 4 weeks prior to randomization or planned during the study.\n6. Cannabinoid treatment within 4 weeks prior to randomization.\n7. Predicted poor compliance with study procedures (e.g., blood tests).\n8. Concurrent use of opiates or alcohol.","ALL","4 Years","13 Years",{"count":80,"type":81},78,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The goal of this clinical trial is to determine whether cannabidiol (CBD, 28%) combined with terpenes and a small amount of THC (1%) can help reduce symptoms of autism, and to evaluate the safety of this treatment.\n\nThe main questions are:\n\n1. Does this treatment improve behavioral challenges in children with autism?\n2. Does this treatment improve social difficulties in children with autism?\n\nWhat will happen in the study:\n\n1. Participants take either the study treatment or a placebo (a look-alike substance with no active drug) every day for 2 months.\n2. After 2 months, all participants receive the study treatment or a similar treatment without THC for another 2 months.\n3. Participants come to the clinic once every 2 months for checkups and tests.",[87,88],"Autism","Autism Spectrum Disorder",[90,91,92,93,94],"autism","ASD","cannabidiol","terpenes","THC","2025-11-15",{"date":97,"type":98},"2025-11-19","ACTUAL",{"date":100,"type":98},"2025-10-05",{"date":102,"type":81},"2028-03-03",{"name":5,"class":6},1]