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)
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.
• 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.