[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bazelet Nehushtan LtD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},78,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Autism","Autism Spectrum Disorder",[31,32,33,34,35],"autism","ASD","cannabidiol","terpenes","THC","RECRUITING","2025-11-15",{"date":39,"type":40},"2025-11-19","ACTUAL",{"date":42,"type":40},"2025-10-05",{"date":44,"type":22},"2028-03-03",{"name":46,"class":47},"Bazelet Nehushtan LtD.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100557771","phase-2-the-safety-and-efficacy-of-terpene-enriched-cannabidiol-cbd-oil-in-adhd-100557771","NCT06542445","The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD","The Safety and Efficacy of Treatment With Cannabidiol (CBD) Oil Enriched With Terpenes, Devoid of THC, in Children Diagnosed With ADHD","Inclusion Criteria:\n\n1. Children\u002Fadolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.\n2. Willing\u002Fable to arrive to all the necessary visits as per study protocol.\n\nExclusion Criteria:\n\n1. Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.\n2. Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere with the study as per PI opinion.\n3. Participants suffering from neurological or psychiatric diseases.\n4. Participants suffering from neoplastic diseases.\n5. Participants with syndromes or metabolic diseases.\n6. Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion.\n7. Pregnant or breastfeeding adolescents.\n8. Sexually active female adolescents who are unwilling to use contraceptives.\n9. Participants that in the PI opinion will not comply with the protocol in a way that will harm the study (for ex.: not using contraceptives.)\n10. Participants with less than 18 kg or more than 90 kg weight.\n11. Participants with BMI lower than 18 or higher than 29.9.\n12. Participants engaged in another clinical study which includes a medicine.\n13. Participants engaged in another study regarding ADHD treatment of any kind.\n14. Participants using alcohol or drugs.\n15. Past or present use of Cannabis, including medical cannabis\n\nCriteria for early termination:\n\n1. Use of another medication for ADHD during the study.\n2. Use of a medication from the exclusion criteria list during the study.\n3. Use of alcohol or drugs during the study.\n4. Participants who got pregnant during the study.\n5. Participants who split the first visit and did not arrive to the second part of the first visit after a maximum of 28 days.\n6. Participants who did not start the treatment during the 14 days from receiving the drug.\n7. Non -compliant participants.\n\nCriteria for exchange:\n\n1. PI may exchange participants that quit, if they did not start treatment for new participants.\n2. PI may recruit again participants who quit after a new full recruitment process.","6 Years","18 Years",{"count":59,"type":22},120,[25],"ADHD is the most frequent neurodevelopmental disorder in childhood. Symptoms often appear in preschool years, and most children (65-80%) continue to experience some ADHD-associated symptoms into adolescence and adulthood. The disorder is marked by age-inappropriate inattention, hyperactivity, and impulsivity. Drug treatments for ADHD include stimulants containing methylphenidate (like Ritalin and Concerta) or amphetamines (like Vyvanse). However, 30-35% of the patients do not respond well to these treatments, and stimulants may result with various side effects.\n\nThe use of medical cannabis increases; applied for expending medical conditions, with growing evidence for its beneficial effects. A study on ADHD adults treated by cannabinoids demonstrated improvements in hyperactivity and impulsivity.\n\nThe current study is aimed to examine the safety and efficacy of treating children diagnosed with ADHD with a CBD oil (devoid of THC), enriched with terpenes. Participants will be randomly assigned to receive either the enriched CBD oil or a placebo, for 5 weeks (Treatment, Stage I).\n\nAt the end of the treatment stage (I), an open-label stage will follow (II), wherein, all participants will receive the investigational product for an additional 5 weeks.\n\nThe investigators hypothesize that children treated with the enriched CBD oil (Treatment, Stage I) will show significantly higher improvement in hyperactivity and inattention scores, as compared with the placebo group.",[63],"Attention Deficit Hyperactivity Disorder (ADHD)",[65,66,67,68],"Cannabidiol","Terpenes","Medical Cannabis","Attention Deficit Hyperactivity Disorder","2024-08-22",{"date":71,"type":40},"2024-08-23",{"date":69,"type":40},{"date":74,"type":22},"2026-09-22",{"name":46,"class":47},""]