NCT07199218 Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
| NCT ID | NCT07199218 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bazelet Nehushtan LtD. |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-10-05 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 78 participants in total. It began in 2025-10-05 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The main questions are: 1. Does this treatment improve behavioral challenges in children with autism? 2. Does this treatment improve social difficulties in children with autism? What will happen in the study: 1. Participants take either the study treatment or a placebo (a look-alike substance with no active drug) every day for 2 months. 2. After 2 months, all participants receive the study treatment or a similar treatment without THC for another 2 months. 3. Participants come to the clinic once every 2 months for checkups and tests.
Eligibility Criteria
Inclusion Criteria: 1. Children aged 4 to 12 years (after the 4th birthday and before the 13th). 2. Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2). 3. 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). 4. Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18. 5. Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66. Exclusion Criteria: 1. Body weight \<12.5 kg or ≥57.5 kg. 2. 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. 3. Seizure or change in antiepileptic medications within 4 months prior to randomization. 4. Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function. 5. 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. 6. Cannabinoid treatment within 4 weeks prior to randomization. 7. Predicted poor compliance with study procedures (e.g., blood tests). 8. Concurrent use of opiates or alcohol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07199218 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 13 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07199218 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07199218 currently recruiting?
Yes, NCT07199218 is actively recruiting participants. Contact the research team at aaran@szmc.org.il for enrollment information.
Where is the NCT07199218 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT07199218 clinical trial?
NCT07199218 is sponsored by Bazelet Nehushtan LtD.. The trial plans to enroll 78 participants.