CBDV vs Placebo in Children With Prader-Willi Syndrome (PWS)

Inclusion Criteria:

1. Male or Female child outpatients aged 5 to 30 years.

2. Diagnosis of PWS confirmed by genetic testing and patient medical records and history.

3. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks
prior to the study start, and for the duration of the study.

4. Have a physical exam and laboratory results that are within the norms for PWS5.
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 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.

5. Score on the Clinical Global Impression Scale Severity (CGI-S) ≥ 4 (moderate severity)
at baseline.

6. Score of ≥18 on the Aberrant Behavior Checklist-Irritability (ABC-I) at baseline.

7. Agree not to drive or operate machinery.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization.

2. Prior chronic treatment with CBD, CBDV or an endo-cannabinoid treatment.

3. Positive testing for THC or other drugs of abuse via urine testing at the screening
visit or baseline visits upon repeat confirmation testing.

4. Lifetime history of drug abuse including marijuana/cannabis use.

5. A primary psychiatric diagnosis other than PWS, including bipolar disorder, psychosis,
schizophrenia, PTSD or MDD. These patients will be excluded due to potential
confounding results.

6. 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 (including but not limited to hepatic or
renal impairment and cardiovascular disease).

7. Known or suspected allergy to CBDV or excipients used in the formulation (i.e.
sesame).

8. Renal, pancreatic, or hematologic dysfunction as evidenced by values above upper
limits of normal for BUN/creatinine, or values twice the upper limit of normal for
serum lipase and amylase, platelets <80,000 /mcL, or WBC<3.0 103 /mcL.

9. Liver dysfunction manifested by > 3 X UNL values of AST or ALT

10. ECG abnormality at baseline screening or clinically significant postural drop in
systolic blood pressure at screening. If the initial screening ECG shows a QTcB of
greater than 460 msec, then 2 additional ECGs will be conducted in the same sitting, 5
minutes apart. If not recognized at screening, then a full triplicate repeat showing
an average QTcB of 460 msec or less to meet all inclusion/exclusion criteria

11. Female subjects who are pregnant will be excluded from the study. If a female subject
is able to become pregnant, she will be given a serum pregnancy test before entry into
the study. Female subjects will be informed not become pregnant while taking CBDV.
Female subjects must tell the investigator and consult an obstetrician or
maternal-fetal specialist if they become pregnant during the study.