Status:
RECRUITING
Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
Lead Sponsor:
Bazelet Nehushtan LtD.
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
All Genders
4-13 years
Phase:
PHASE2
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 t...
Detailed Description
Autism spectrum disorder (ASD) is a condition that affects communication, social interaction, and behavior. Current medications do not treat the core symptoms of autism, and the drugs sometimes prescr...
Eligibility Criteria
Inclusion
- Children aged 4 to 12 years (after the 4th birthday and before the 13th).
- Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2).
- 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).
- Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18.
- Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66.
Exclusion
- Body weight \<12.5 kg or ≥57.5 kg.
- 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.
- Seizure or change in antiepileptic medications within 4 months prior to randomization.
- Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.
- 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.
- Cannabinoid treatment within 4 weeks prior to randomization.
- Predicted poor compliance with study procedures (e.g., blood tests).
- Concurrent use of opiates or alcohol.
Key Trial Info
Start Date :
October 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 3 2028
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT07199218
Start Date
October 5 2025
End Date
March 3 2028
Last Update
November 19 2025
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, N/A = Not Applicable, Israel, 9640610