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

A Double-blind, Randomized, Two-period Crossover Study Evaluating the Effects of Tasimelteon vs. Placebo on Sleep Disturbances of Individuals With Smith-Magenis Syndrome (SMS)

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

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 3- 65 years of age
4. Recent history of sleep disturbances
5. Have an appointed care-giver complete the required outpatient assessments
6. Willing and able to comply with study requirements and restrictions

Exclusion Criteria:

1. Unable to dose daily with medication
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