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

• Sponsor: Vanda Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03154697
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 179
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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	Phase
Sleep Disturbances in Smith-Magenis Syndrome	Other: Data collection of sleep disturbances in individuals with SMS

Study Design

• Study Type: Observational
• Anticipated 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: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2030
• Anticipated Study Completion Date: Dec 1, 2030

Outcome Measures

Primary Outcome Measures

1. Number of individuals with Smith- Magenis syndrome [5 years]

Secondary Outcome Measures

1. Sleep Disturbances [Up to 100 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Not legal guardian of individual with SMS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Pharmaceuticals	Washington, D.C.	District of Columbia	United States	20037

Sponsors and Collaborators

• Vanda Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vanda Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03154697
• Other Study ID Numbers: Pro00015678
• First Posted: May 16, 2017
• Last Update Posted: May 16, 2017
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Smith-Magenis Syndrome; Syndrome

Study Results

No Results Posted as of May 16, 2017