drugset / Trial / NCT07199218

Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism

NCT07199218

Phase 2 Recruiting 78 enrolled Bazelet Nehushtan LtD.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-10-05
Primary completion
2027-12-31
Completion
2028-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 7.2 mg/kg Oral
Subject Dronabinol Other / unclassified 0.257 mg/kg Oral

Indications