Sleep Disturbances in Smith-Magenis Syndrome Clinical Trial
Official title:
Development of Clinical Database of Individuals With Smith-Magenis Syndrome
| NCT number | NCT03154697 |
| Other study ID # | Pro00015678 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2016 |
| Est. completion date | December 2030 |
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.
| Status | Recruiting |
| Enrollment | 1000 |
| Est. completion date | December 2030 |
| Est. primary completion date | December 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Parent or legal guardian of individual with Smith-Magenis Syndrome Exclusion Criteria: - Not legal guardian of individual with SMS |
| Country | Name | City | State |
|---|---|---|---|
| United States | Vanda Pharmaceuticals | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Vanda Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of individuals with Smith- Magenis syndrome | 5 years | ||
| Secondary | Sleep Disturbances | Up to 100 weeks |