CBDV for Prader-Willi Syndrome
Trial Summary
Will I have to stop taking my current medications?
The trial requires that your current medications be stable for at least 4 weeks before starting and throughout the study, so you should not stop taking them if they are stable.
What data supports the effectiveness of the drug CBDV for Prader-Willi Syndrome?
Research shows that CBDV, a compound similar to CBD, has been beneficial in improving neurological and social deficits in conditions like Rett syndrome, which shares some symptoms with Prader-Willi Syndrome. This suggests potential benefits of CBDV for Prader-Willi Syndrome, although direct evidence is not yet available.12345
Is CBDV safe for humans?
How does the drug CBDV differ from other treatments for Prader-Willi Syndrome?
CBDV is unique because it is a non-psychotropic compound derived from Cannabis sativa, which means it doesn't cause the 'high' associated with cannabis. It has shown potential in treating neurological conditions like epilepsy and autism spectrum disorders by interacting with specific receptors in the brain, which may offer a novel approach for managing symptoms of Prader-Willi Syndrome.12357
What is the purpose of this trial?
This study tests if a safe cannabis compound that doesn't cause a high can help reduce irritability in children and young adults with Prader-Willi Syndrome.
Research Team
Eric Hollander, MD
Principal Investigator
Montefiore Medical Center/Albert Einstein College of Medicine
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
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
Treatment Details
Interventions
- CBDV Compound
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
GW Pharmaceuticals Ltd
Industry Sponsor
Foundation for Prader-Willi Research
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