CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) (NCT03848481) | Clinical Trial Compass
TerminatedPhase 2
CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS)
Stopped: Only limited funding was available and the study was never able to be conducted to its natural conclusion.
United States6 participantsStarted 2020-11-23
Plain-language summary
This study aims to examine the feasibility and safety of cannabidivarin (CBDV) as a treatment for children and young adults with PWS.
Who can participate
Age range5 Years – 30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or Female outpatients aged 5 to 30 years.
✓. Diagnosis of PWS confirmed by genetic testing and patient medical records and history.
✓. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to the study start, and for the duration of the study.
✓. Have a physical exam and laboratory results that are within the norms for PWS
✓. 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.
✓. Score on the Clinical Global Impression Scale Severity (CGI-S) ≥ 4 (moderate severity) at baseline.
✓. Score of ≥18 on the Aberrant Behavior Checklist-Irritability (ABC-I) at baseline.
✓. Agree not to drive or operate machinery.
Exclusion criteria
✕. Exposure to any investigational agent in the 30 days prior to randomization.
✕. Prior chronic treatment with CBD or CBDV.
✕. Positive testing for THC or other drugs of abuse via urine testing at the screening visit or baseline visits upon repeat confirmation testing.
What they're measuring
1
Irritability Based on Aberrant Behavior Checklist-Irritability (ABC-I) Subscale
✕. History of Drug Abuse Disorder including Cannabis Use Disorder
✕. A primary psychiatric diagnosis other than PWS, including bipolar disorder, psychosis, schizophrenia, Post-Traumatic Stress Disorder (PTSD), or Major Depressive Disorder (MDD). These patients will be excluded due to potential confounding results.
✕. 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).
✕. Known or suspected allergy to CBDV or excipients used in the formulation (i.e. sesame).
✕. Clinical indications of renal, pancreatic, or hematologic dysfunction as evidenced by values above upper limits of normal for Blood Urea Nitrogen (BUN)/creatinine, values twice the upper limit of normal for serum lipase and amylase, platelets \<80,000 /microliter, white blood cell (WBC)\<3.0 103 /microliter or \> 2x Upper Limit of Normal (UNL) values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT).