Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

Criteria

Inclusion Criteria:

1. A confirmed clinical diagnosis of SMS

2. Informed consent from the patient or the legal guardian

3. Male or female between the ages of 16- 65 years of age

4. History of sleep disturbances

5. Willing and able to comply with study requirements and restrictions

Exclusion Criteria:

1. Unable to dose daily with medication and have an appointed care-giver complete the required outpatient assessments

2. Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening

3. Any other sound medical reason as determined by the clinical investigator