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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Terpenes-Enriched CBD-Predominant Oil
DrugOral cannabidiol (CBD; 7.2 mg/kg/day), tetrahydrocannabinol (THC; 0.257 mg/kg/day, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD/THC: 280/10 mg per g) produced by Bazelet Group, Israel.
Placebo
DrugOral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses.
Terpenes-Enriched CBD Oil (THC-Free)
DrugOral cannabidiol (CBD; 7.2 mg/kg/day) and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD- 280 mg per g) produced by Bazelet Group, Israel.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Terpenes-Enriched CBD-Predominant OilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change From Baseline in Aberrant Behavior Checklist-Community (ABC-C): Irritability Subscale raw score (ABC-I)
The ABC-C is a caregiver-completed questionnaire with 58 items, divided into five subscales. The ABC-I (Irritability) subscale includes 15 items that assess emotional and behavioral symptoms of ASD, such as aggression toward others, deliberate self-injury, temper tantrums, depressed mood, and rapidly shifting moods. Scores on this subscale range from 0 to 45, with higher scores indicating greater severity. Change from baseline to Week 8 is reported, with lower scores reflecting clinical improvement.
Time frame
Baseline to Week 8Secondary outcomes
1
Change From Baseline in Vineland™-III Adaptive Behavior Scales (VABS3) Socialization Domain Standard Score
The VABS-3 Socialization domain measures interpersonal relationships, play and leisure, and coping skills, reflecting the individual's ability to engage in age-appropriate social interactions. Higher scores indicate better adaptive social functioning.
Time frame
Baseline to Week 82
Change From Baseline in Social Responsiveness Scale-2nd edition (SRS-II) total raw score
The SRS-2 measures the severity of social impairment associated with autism spectrum disorder. It includes five subscales: Social Awareness (8 items), Social Communication (22 items), Social Cognition (12 items), Social Motivation (11 items), and Restricted Interests and Repetitive Behavior (12 items). Two summary scores are derived: the Total Score (sum of all five subscales) and the Social Communication and Interaction (SCI) score, which combines the four social subscales excluding Restricted Interests and Repetitive Behavior. The SCI and RRB correspond to the two DSM-5 symptom domains of autism spectrum disorder. Raw scores range from 65 to 260; higher scores indicate greater severity of social impairment.
Time frame
Baseline, Weeks 8 and 173
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Participants experiencing at least one adverse event that newly appeared or worsened after treatment initiation. Adverse events are graded as mild, moderate, or severe; hospitalizations are documented as serious adverse events; causality is categorized from not related to definitely related.
Time frame
Baseline to Week 174
Number of Participants With Clinically Significant Abnormal Laboratory Values
Number of participants with clinically significant abnormal values in complete blood count (CBC), liver transaminases, or total bilirubin levels, as determined by the investigator.
Time frame
Week 8Other outcomes
1
Change From Baseline in Aberrant Behavior Checklist-Community (ABC-C): Irritability Subscale raw score (ABC-I)
Appears above
Time frame
Baseline, Week 172
Change From Baseline in Vineland™ Adaptive Behavior Scales (VABS-3) Communication Domain Score
The VABS-3 Communication domain measures receptive, expressive, and written language skills. Higher Communication scores indicate better adaptive functioning
Time frame
Baseline to Week 83
Change From Baseline in Vineland™ Adaptive Behavior Scales (VABS-3) Maladaptive Behavior Domain Score
The VABS-3 Maladaptive Behavior domain measures internalizing, externalizing, and other maladaptive behaviors. Higher Maladaptive Behavior scores indicate greater difficulties.
Time frame
Baseline to Week 84
Change From Baseline in Emotion Dysregulation Inventory (EDI)
The EDI measures the intensity and reactivity of emotional responses, reflecting difficulties with emotion regulation; scores range from 0 to 120, with higher scores indicating greater emotion dysregulation.
Time frame
Baseline, Weeks 8 and 17Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bazelet Nehushtan LtD.
Lead sponsor
Shaare Zedek Medical Center
Sponsor institution
Source ClinicalTrials.gov