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 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 12:23 AM
NCT ID:
NCT02013258
Eligibility Criteria:
Inclusion Criteria:
* Children with genetically confirmed PWS
* Ages at ≥ 5 years and ≤ 11 years (must start treatment prior to 11th birthday)
* Child must be in nutritional phase 2b or 3, as determined by the PI at each site.
* Must currently be on growth hormone treatment, and have been receiving growth hormone treatment for at least one year prior to screening date.
* Treatment cannot have been interrupted for more than 1 week within 3 months prior to screening date.
* Priority will be given to children currently enrolled in the RDCRN Natural History study
Exclusion Criteria:
* Inability to tolerate intranasal administration of medication
* Hepatic insufficiency (AST/ALT greater than 3 times the normal levels for age)
* Renal insufficiency (BUN/Creatinine greater than 3 times the normal levels for age)
* History of an abnormal ECG (as determined by a cardiologist). If there is any question about cardiac function, ECG reports will be reviewed with a cardiologist prior to enrollment in the study.
* Child not receiving growth hormone treatment
* Child with hypertension or hypotension for age and sex (blood pressure \>97% for age and sex or blood pressure \<3% for age and sex)
* Diabetes mellitus
* Pregnant or lactating.
* Schizophrenia or psychosis
* Taking any psychotropic medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT02013258
Study Brief:
Protocol Section:
NCT02013258