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New treatment option for Autism Spectrum Disorder
Official title Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
ClinicalTrials.gov ID: NCT03202303
What this study is testing
What is Cannabidivarin?
Cannabidivarin is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for autism spectrum disorder.
Also referred to as CBDV.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18
You may be able to join if
- Male or Female pediatric outpatients aged between and including ages 5 to 18. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and...
- Aberrant Behavior Checklist (ABC) - Irritability Subscale (ABC-I) score of 18 or greater at screening visit.
- Social Responsiveness Scale (SRS) score of 66T or higher at screening visit.
- Clinical Global Impression Scale - Severity (CGI-S) score of 4 or higher at screening.
- Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to randomization and for the duration of the study.
You likely can't join if
- Exposure to any investigational agent in the 30 days prior to randomization.
- Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment.
- Positive testing for THC or other drugs of abuse via urine testing at the screening visit or baseline visits upon repeat confirmation testing.
- Recent history of drug abuse including marijuana/cannabis use in the past 3 months.
- Diagnosis of a known genetic disorder (ie. Prader-Willi Syndrome, Angelman Syndrome etc.).
- A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, Post-Traumatic Stress Disorder (PTSD) or Major...
See the full eligibility criteria
- Male or Female pediatric outpatients aged between and including ages 5 to 18. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria.\ During special circumstances (e.g. COVID-19...
- Aberrant Behavior Checklist (ABC) - Irritability Subscale (ABC-I) score of 18 or greater at screening visit.
- Social Responsiveness Scale (SRS) score of 66T or higher at screening visit.
- Clinical Global Impression Scale - Severity (CGI-S) score of 4 or higher at screening.
- Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to randomization and for the duration of the study.
- Physical exam and laboratory results that are within normal range for individuals with ASD.
- Presence of a parent/caregiver/guardian that is able to consent for their participation and complete assessments regarding the child's development and behavior throughout the study. Child Assent will be obtained if the...
- Exposure to any investigational agent in the 30 days prior to randomization.
- Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment.
- Positive testing for THC or other drugs of abuse via urine testing at the screening visit or baseline visits upon repeat confirmation testing.
- Recent history of drug abuse including marijuana/cannabis use in the past 3 months.
- Diagnosis of a known genetic disorder (ie. Prader-Willi Syndrome, Angelman Syndrome etc.).
- A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, Post-Traumatic Stress Disorder (PTSD) or Major Depressive Disorder (MDD). These patients will be excluded due to...
- A medical condition that severely impacts the subject's ability to participate in the study, interferes with the conduct of the study, confounds interpretation of study results or endangers the subject's well-being.
- A known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or marked sensory impairment such as deafness or blindness.
- people who have had changes in allied health therapies, behavioral or educational interventions within four weeks prior to randomization other than those associated with school holidays.
- people who have had changes in medications or medication doses within four weeks of randomization. Renal, pancreatic, or hematologic dysfunction as evidenced by values above upper limits of normal for BUN/creatinine, or...
- Liver dysfunction manifested by \> 2 X UNL values of AST or ALT
- ECG abnormality at baseline screening or clinically significant postural drop in systolic blood pressure at screening. If the initial screening ECG show a QTcB of greater than 460 msec, then 2 additional ECGs will be...
- Known allergy to sesame oil
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.