Recruiting

Observational Study

Sponsor:

Vanda Pharmaceuticals

Code:

NCT03154697

Conditions

Sleep Disturbances in Smith-Magenis Syndrome

Eligibility Criteria

Sex: All

Age: 3 - 65

Healthy Volunteers: Not accepted

Interventions

Data collection of sleep disturbances in individuals with SMS

Study Details

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.

Conditions

Sleep Disturbances in Smith-Magenis Syndrome

Study ID

NCT03154697

Start date

Jan, 2016

Status verified date

Oct, 2018

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Not legal guardian of individual with SMS

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Locations

Vanda Pharmaceuticals

Recruiting

Washington, District of Columbia, United States, 20037

Contacts

Vanda Pharmaceuticals

202-734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Mar 20, 2024

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2024-03-20.