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Trial record 97 of 663 for:    SMS

Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)

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ClinicalTrials.gov Identifier: NCT02180451
Recruitment Status : Unknown
Verified March 2016 by Vanda Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : July 2, 2014
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Brief Summary:
The purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes

Condition or disease
Smith Magenis Syndrome

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)
Study Start Date : June 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin




Primary Outcome Measures :
  1. Circadian melatonin rhythm as measured by plasma melatonin [ Time Frame: 36-hour blood sampling on week 1 ]
  2. Circadian melatonin rhythm as measured by plasma melatonin [ Time Frame: 36-hour blood sampling on week 2 ]
  3. Circadian melatonin rhythm as measured by plasma melatonin [ Time Frame: 36-hour blood sampling on week 4 ]
  4. Circadian cortisol rhythms as measured by plasma cortisol [ Time Frame: 36-hour blood sampling at week 1 ]
  5. Circadian cortisol rhythms as measured by plasma cortisol [ Time Frame: 36-hour blood sampling at week 2 ]
  6. Circadian cortisol rhythms as measured by plasma cortisol [ Time Frame: 36-hour blood sampling at week 4 ]
  7. Circadian analytes rhythms as measured in plasma [ Time Frame: 36-hour blood sampling at week 1 ]
  8. Circadian analytes rhythms as measured in plasma [ Time Frame: 36-hour blood sampling at week 2 ]
  9. Circadian analytes rhythms as measured in plasma [ Time Frame: 36-hour blood sampling at week 4 ]

Secondary Outcome Measures :
  1. Genetic testing to confirm SMS diagnosis [ Time Frame: blood sampling at screening visit ]
  2. Nighttime and daytime sleep as measured by actigraphy [ Time Frame: Four week evaluation period ]
  3. QOL Scale [ Time Frame: Four week evaluation period ]
  4. Melatonin Light Response Test (MLRT) [ Time Frame: After four week evaluation period ]
  5. Behavioral Scale [ Time Frame: Four week evaluation period ]
  6. Salivary melatonin and cortisol [ Time Frame: Four week evaluation period ]

Biospecimen Retention:   Samples With DNA
Melatonin and Cortisol samples will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Smith-Magenis patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180451


Locations
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United States, Maryland
Baltimore, Maryland, United States
Sponsors and Collaborators
Vanda Pharmaceuticals

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02180451     History of Changes
Other Study ID Numbers: VP-1401
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Smith-Magenis Syndrome
Syndrome
Disease
Pathologic Processes
Chronobiology Disorders
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Hydrocortisone
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Inflammatory Agents