NCT07199218RecruitingPhase 2
Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 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/C28, Administered to Pediatric Subjects With Autism Spectrum Disorder (ASD)
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 5 Oct 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Bazelet Nehushtan LtD.
- Diseases
- Autism
- NCT number
- NCT07199218
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 78
- From 5 Oct 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Seizure or change in antiepileptic medications within 4 months prior to randomization.
- 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.
- Concurrent use of opiates or alcohol.
Other illness
- 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.
Lab values
- Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.
Other
- Body weight \<12.5 kg or ≥57.5 kg.
- Predicted poor compliance with study procedures (e.g., blood tests).
Who the study is looking for
- 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.
Age in the registry: 4 years to 13 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.