Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02180451
Recruitment Status : Unknown
Verified March 2016 by Vanda Pharmaceuticals. Recruitment status was: Active, not recruiting
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
6 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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