Your session is about to expire
← Back to Search
Cannabinoid
Cannabidivarin for Autism Spectrum Disorder
Phase 2
Recruiting
Led By Eric Hollander, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or Female pediatric outpatients aged between and including ages 5 to 18 with a diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria (or ADI-R under special circumstances)
Be younger than 65 years old
Must not have
Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment
Diagnosis of a known genetic disorder (ie. Prader-Willi Syndrome, Angelman Syndrome etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in vineland-3 from baseline to week 12 (change over 12 weeks)
Summary
This trial is testing whether a cannabis-based drug called cannabidivarin (CBDV) is effective and safe in treating children with autism spectrum disorder (ASD).
Who is the study for?
This trial is for children aged 5-18 with Autism Spectrum Disorder, confirmed by specific diagnostic criteria. They must have stable treatments and a caregiver to consent and assess their behavior. Excluded are those with recent drug use, certain medical conditions, medication changes within the last month, or known allergies to sesame oil.
What is being tested?
The study tests Cannabidivarin (CBDV) against a placebo in children with ASD to evaluate its effectiveness and safety. Participants will be randomly assigned to receive either CBDV or an inactive substance that looks the same as CBDV.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of CBDV may include drowsiness, gastrointestinal issues like diarrhea or appetite changes, and possible interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 5 to 18 years old and have been diagnosed with Autism Spectrum Disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been on long-term treatment with CBD or similar.
Select...
I have been diagnosed with a genetic disorder.
Select...
My primary mental health condition is not ASD, but includes conditions like bipolar disorder or PTSD.
Select...
I have Rett Syndrome, Childhood Disintegrative Disorder, or a severe sensory impairment like deafness or blindness.
Select...
I am pregnant or can become pregnant and am not using birth control.
Select...
My kidney, pancreas, or blood is not functioning properly based on specific lab tests.
Select...
I have an abnormal heart test result or a significant drop in blood pressure when standing.
Select...
My liver tests are more than twice the normal limit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in vineland-3 from baseline to week 12 (change over 12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in vineland-3 from baseline to week 12 (change over 12 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aberrant Behavior Checklist-Irritability Subscale (ABC-I)
Secondary study objectives
Aberrant Behavior Checklist-Social Withdrawal Subscale (ABC-SW)
Clinical Global Impressions-Improvement (CGI-I)
Montefiore Einstein Rigidity Scale-Revised (MERS-R)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidivarin (CBDV)Experimental Treatment1 Intervention
Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks
Group II: Matched PlaceboPlacebo Group1 Intervention
Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks
Find a Location
Who is running the clinical trial?
GW Pharmaceuticals LtdIndustry Sponsor
10 Previous Clinical Trials
1,163 Total Patients Enrolled
Montefiore Medical CenterLead Sponsor
458 Previous Clinical Trials
588,514 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
64 Patients Enrolled for Autism Spectrum Disorder
United States Department of DefenseFED
916 Previous Clinical Trials
334,617 Total Patients Enrolled
18 Trials studying Autism Spectrum Disorder
1,660 Patients Enrolled for Autism Spectrum Disorder
Jazz PharmaceuticalsIndustry Sponsor
251 Previous Clinical Trials
34,934 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
109 Patients Enrolled for Autism Spectrum Disorder
Eric Hollander, MDPrincipal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine
16 Previous Clinical Trials
549 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
54 Patients Enrolled for Autism Spectrum Disorder