Cannabidivarin for Autism Spectrum Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
Will I have to stop taking my current medications?
The trial requires that participants have stable medication doses for at least four weeks before joining and throughout the study, so you should not change your current medications during this time.
Is Cannabidivarin (CBDV) safe for humans?
Cannabidivarin (CBDV) has been studied for its potential therapeutic effects in neurological conditions like epilepsy and autism spectrum disorder. While specific safety data for CBDV in humans is limited, studies on similar compounds like cannabidiol (CBD) suggest that they are generally well-tolerated with mild side effects. More research is needed to fully understand the safety profile of CBDV in humans.12345
How is the drug Cannabidivarin (CBDV) unique in treating Autism Spectrum Disorder?
Cannabidivarin (CBDV) is unique because it is a non-intoxicating compound derived from the Cannabis sativa plant that may modulate brain systems involved in autism, specifically affecting the balance of excitatory and inhibitory neurotransmitters like glutamate and GABA. Unlike other treatments, CBDV's potential to improve core symptoms of autism is still being explored, and it shows promise with low adverse effects.45678
What data supports the effectiveness of the drug Cannabidivarin for Autism Spectrum Disorder?
Who Is on the Research Team?
Eric Hollander, MD
Principal Investigator
Montefiore Medical Center/Albert Einstein College of Medicine
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weight-based dosing of 10 mg/kg/day of CBDV or placebo for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidivarin
- Matched Placebo
Cannabidivarin is already approved in European Union for the following indications:
- Orphan designation for Rett Syndrome and Fragile X Syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
GW Pharmaceuticals Ltd
Industry Sponsor
United States Department of Defense
Collaborator
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland