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Cannabinoid

CBDV for Prader-Willi Syndrome

Phase 2
Waitlist Available
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
Presence of a parent/caregiver/guardian that is able to consent for their participation and complete assessments regarding the patient's development and behavior throughout the study. Child Assent will be obtained if the subject is 7 years of age or older and has the mental capacity to understand and sign a written assent form and/or give verbal assent.
Male or Female outpatients aged 5 to 30 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12
Awards & highlights

Study Summary

This trial is studying if cannabidivarin is an effective and safe treatment for children with Prader-Willi Syndrome.

Who is the study for?
This trial is for children and young adults aged 5 to 30 with Prader-Willi Syndrome, confirmed by genetic testing. Participants must have stable treatments for 4 weeks prior and during the study, no drug abuse history, and not be pregnant or become pregnant. They should score moderately severe on specific behavioral scales.Check my eligibility
What is being tested?
The study tests cannabidivarin (CBDV) against a placebo in managing PWS symptoms. It assesses CBDV's safety and effectiveness through physical exams, lab results within PWS norms, caregiver assessments, and behavior checklists.See study design
What are the potential side effects?
Potential side effects of CBDV are not detailed in this summary but would typically include monitoring for any adverse reactions compared to the placebo group since it's a feasibility and safety trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a guardian who can consent for me and help with my study assessments.
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I am between 5 and 30 years old.
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My Prader-Willi Syndrome diagnosis is confirmed by genetic tests.
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My current treatments or lifestyle changes for my condition have been stable for the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 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
Lethargy
ActiGraph GT9X-BT activity monitors
Caregiver Strain Questionnaire (CSQ)
+5 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
440 Previous Clinical Trials
581,597 Total Patients Enrolled
3 Trials studying Prader-Willi Syndrome
21,033 Patients Enrolled for Prader-Willi Syndrome
Foundation for Prader-Willi ResearchOTHER
13 Previous Clinical Trials
1,174 Total Patients Enrolled
12 Trials studying Prader-Willi Syndrome
994 Patients Enrolled for Prader-Willi Syndrome
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,345 Total Patients Enrolled

Media Library

CBDV Compound (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT03848481 — Phase 2
Prader-Willi Syndrome Research Study Groups: Matched Placebo, Cannabidivarin (CBDV)
Prader-Willi Syndrome Clinical Trial 2023: CBDV Compound Highlights & Side Effects. Trial Name: NCT03848481 — Phase 2
CBDV Compound (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03848481 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Aug 2024