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

Overview

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.

Full Title of Study: “Development of Clinical Database of Individuals With Smith-Magenis Syndrome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 2030

Interventions

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of individuals with Smith- Magenis syndrome
    • Time Frame: 5 years

Secondary Measures

  • Sleep Disturbances
    • Time Frame: Up to 100 weeks

Participating in This Clinical Trial

Inclusion Criteria

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

  • Not legal guardian of individual with SMS

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanda Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Vanda Pharmaceuticals, 202-734-3400, clinicaltrials@vandapharma.com

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