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Trial record 60 of 662 for:    SMS

Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances

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ClinicalTrials.gov Identifier: NCT03154697
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Brief Summary:
This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.

Condition or disease Intervention/treatment
Sleep Disturbances in Smith-Magenis Syndrome Other: Data collection of sleep disturbances in individuals with SMS

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of Clinical Database of Individuals With Smith-Magenis Syndrome
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders


Intervention Details:
  • Other: Data collection of sleep disturbances in individuals with SMS
    Data related to Smith-Magenis syndrome and sleep disturbances are collected through a web or phone survey


Primary Outcome Measures :
  1. Number of individuals with Smith- Magenis syndrome [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Sleep Disturbances [ Time Frame: Up to 100 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with SMS
Criteria

Inclusion Criteria:

  • Parent or legal guardian of individual with Smith-Magenis Syndrome

Exclusion Criteria:

  • Not legal guardian of individual with SMS

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): NCT03154697


Contacts
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Contact: Vanda Pharmaceuticals 855-798-2632

Locations
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United States, District of Columbia
Vanda Pharmaceuticals Recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Vanda Pharmaceuticals    855-798-2632      
Sponsors and Collaborators
Vanda Pharmaceuticals

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03154697     History of Changes
Other Study ID Numbers: Pro00015678
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Smith-Magenis Syndrome
Dyssomnias
Sleep Wake Disorders
Parasomnias
Syndrome
Disease
Pathologic Processes
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Chronobiology Disorders
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn