Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Radius Pharmaceuticals, Inc.
Age
8–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females between 8 and 65 years of age (inclusive) at Screening.
Genetically confirmed diagnosis of PWS. Documentation of genetically confirmed diagnosis of PWS is acceptable.
The same caregiver is available to complete the questionnaire throughout the duration of the study.
After completion of the Tolerability period, participants will have a mean Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score ≥13 and a decrease of HQ-CT score no more than 7 during Tolerability (run-in) period.
If receiving growth hormone, psychotropic therapy, metabolic treatments that could affect appetite (including metformin), and other treatment including thyroid hormone, must be on the same medication and dose for at least 90 days prior to consent/assent
You may not be if
Known use of cannabis or cannabinoid containing products (including topical products) within 90 days prior to consent/ assent.
Use of prescription or over-the-counter weight loss agents within 90 days prior to consent/assent.
Implementation of new food or environmental restrictions within 90 days of consent/ assent.
If living in a group home, participant spends less than 25 waking hours with their caregiver per week.
Uncontrolled chronic conditions (diabetes, sleep apnea, etc.) as determined by the Investigator.
