Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02011360
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of Prader Willi syndrome confirmed by chromosome analysis (ie. interstitial deletion of paternally-derived chromosome 15q, uniparental maternal disomy or other chromosome 15 abnormalities)
* age 5 years to 17 years
* written informed consent and assent obtained and willingness to comply with the study schedule and procedures
* free T4, TSH values in the normal range (either endogenous or with thyroxine replacement)
* weight stable (BMI percentile fluctuation of \<5 percentiles) over the preceding 2 months prior to the study
Exclusion Criteria:
* presence of other clinically significant disease that would impact body composition including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
* concomitant use of medications known to affect body weight or investigational drug in the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT02011360
Study Brief:
Protocol Section:
NCT02011360