Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-13
SponsorBazelet Nehushtan LtD.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Terpenes-Enriched CBD-Predominant Oil
- Placebo
- Terpenes-Enriched CBD Oil (THC-Free)
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Bazelet Nehushtan LtD.
Lead sponsor
Shaare Zedek Medical Center
Sponsor institution
Source ClinicalTrials.gov