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:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT02180451
Eligibility Criteria:
Inclusion Criteria:
* A confirmed clinical diagnosis of SMS with a prior positive genetic test result as indicated by a parent/guardian
* Informed consent from the patient or the legal guardian/assent provided by the individual with SMS, when possible
* Male or female between the ages of 6-50 years of age
* History of sleep disturbances
* Willing and able to comply with study requirements and restrictions
Exclusion Criteria:
* Failure to confirm diagnosis of SMS by molecular cytogenetic methods and/or DNA-based mutation analysis of the RAI1 gene
* Totally blind with no light perception
* Institutionalized or living in an assisted living facility
* Unwilling or unable to follow medication restrictions (medications that affect sleep or melatonin secretion) or unwilling or unable to sufficiently wash-out from use of a restricted medication
* Any medical condition, as determined by the clinical investigator that would make it unsafe for blood draws (e.g., anemia, blood clotting disorders, anxiety, etc.)
* Any other sound medical reason as determined by the clinical investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
50 Years
Study:
NCT02180451
Study Brief:
Protocol Section:
NCT02180451