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

Recruiting

• Conditions: Sleep Disturbances in Smith-Magenis Syndrome

• Registration Number: NCT03154697
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Status Verified: 2018-10
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• Not legal guardian of individual with SMS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of individuals with Smith- Magenis syndrome	5 years

Secondary Outcome Measures

Name	Time	Method
Sleep Disturbances	Up to 100 weeks

Trial Locations

Locations (1)

Vanda Pharmaceuticals; 🇺🇸 Washington, District of Columbia, United States