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CBDV for Prader-Willi Syndrome
Study Summary
This trial is studying if cannabidivarin is an effective and safe treatment for children with Prader-Willi Syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant and will take a pregnancy test if I can become pregnant. I agree not to become pregnant while taking CBDV.You have a known or suspected allergy to CBDV or any of the ingredients used in the medicine, like sesame.You have a history of drug addiction, including problems with cannabis.I have a guardian who can consent for me and help with my study assessments.I do not have any health conditions that would make it unsafe for me to join the study.I am between 5 and 30 years old.My Prader-Willi Syndrome diagnosis is confirmed by genetic tests.I do not have bipolar disorder, psychosis, schizophrenia, PTSD, or major depression.My blood tests show kidney, pancreas, or blood issues.I have been on long-term treatment with CBD or CBDV.My current treatments or lifestyle changes for my condition have been stable for the last 4 weeks.
- Group 1: Matched Placebo
- Group 2: Cannabidivarin (CBDV)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are people of all ages welcome in this clinical trial, or are there age restrictions?
"For this particular clinical trial, only individuals aged 5-30 are eligible to apply. In contrast, there are 390 other trials that welcome patients under 18 and 1034 for people over 65."
To whom does this study apply? Who can sign up to participate?
"26 individuals will be accepted into this trial. These participants must meet the following two criteria: they should have royer syndrome and be aged between 5-30 years old."
Are patients being accepted for this trial at this time?
"That is correct. The listing on clinicaltrials.gov currently indicates that the trial is recruiting, with a start date of 11/23/2020 and most recent update on 8/17/2022. They are looking for 26 individuals total at 1 site."
Does the FDA condone CBDV as a viable medication?
"At Power, we gave CBDV Compound a score of 2 for safety. This is because while there is some data supporting its safety, none of the available evidence suggests that it effective."
How many people total are in this experimental group?
"Yes, according to the latest information on clinicaltrials.gov, this study is still actively recruiting participants. The trial was originally posted on November 23rd, 2020 and was last updated on August 17th, 2022. 26 participants are needed for the trial at 1 location."
Will this clinical trial offer novel treatments?
"There have been a total of 18,290 clinical trials conducted since 2019. Of these, 2 are still active and testing CBDV Compound in 1 city across 1 nation. The first study began in 2019 and was sponsored by Jazz Pharmaceuticals. It completed Phase 2 approval with 100 participants."
Could you tell me if there is any prior research on CBDV Compound's efficacy?
"Currently, there are two on-going trials for CBDV Compound. However, neither of the active trials are in Phase 3. Most of the trials taking place for this compound are based in Bronx, New york; though there are two trial sites outside of that area."
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