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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in vineland-3 from baseline to week 12 (change over 12 weeks)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am between 5 to 18 years old and have been diagnosed with Autism Spectrum Disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in vineland-3 from baseline to week 12 (change over 12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in vineland-3 from baseline to week 12 (change over 12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aberrant Behavior Checklist-Irritability Subscale (ABC-I)
Secondary outcome measures
Aberrant Behavior Checklist-Social Withdrawal Subscale (ABC-SW)
Clinical Global Impressions-Improvement (CGI-I)
Montefiore Einstein Rigidity Scale-Revised (MERS-R)
+3 more

Trial 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?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,176 Total Patients Enrolled
United States Department of DefenseFED
864 Previous Clinical Trials
327,499 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,185 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals eligible to take part in the experiment?

"For this clinical trial, participants must be between 5 and 18 years of age."

Answered by AI

Is this research endeavor the inaugural of its kind?

"To date, only one trial for Cannabidivarin has been conducted across one city and country. Initial data was gathered in 2019 by Jazz Pharmaceuticals as part of a Phase 2 drug approval process with 100 participants. Since then, 15 more studies have taken place."

Answered by AI

What is the scope of this clinical trial in terms of participant numbers?

"Affirmative, the information on clinicaltrials.gov alludes to this experiment's current recruitment of participants. The trial was initially posted on April 12th 2019 and recently revised on September 21st 2022. A hundred individuals need to be enrolled from one medical centre for this study."

Answered by AI

What criteria must a participant meet in order to qualify for this research program?

"This research trial is seeking 100 children aged between 5 and 18 years, with a confirmed diagnosis of Autism Spectrum Disorder (ASD) as indicated by ADOS-2 and DSM-5 criteria. For special cases such as the COVID-19 pandemic where face masks are mandatory, eligibility may be assessed using the Autism Diagnostic Interview, Revised (ADI-R). Furthermore, participants must have stayed on consistent pharmacologic, educational or dietary interventions for four weeks prior to randomization until completion of the study; possess parental/caregiver consent; offer child assent if seven years or older and demonstrating mental capacity to understand forms;"

Answered by AI

Has Cannabidivarin garnered the official endorsement of the Food and Drug Administration?

"Based on the available data, Cannabidivarin's safety was scored a 2. This assessment is informed by Phase 2 trial results that tout its security but no efficacy information as of yet."

Answered by AI

Are there any openings in this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov verifies that this research endeavour is looking for participants; it was initially posted in April 2019, and the most recent alteration occurred on September 2021. In total, 100 people are needed to be recruited from one particular medical centre."

Answered by AI

Has Cannabidivarin been assessed in other medical experiments?

"Currently, there is one active clinical trial exploring Cannabidivarin. Notably, it has not progressed to the final phase yet. Most of these investigations are located in Bronx, New york with a single outlier elsewhere."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Connecticut
New York
How old are they?
18 - 65
< 18
What site did they apply to?
Montefiore Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
2019. "Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03202303.
All > Asd > Autism
~3 spots leftby Jul 2024
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