Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| Contact: | Vanda Pharmaceuticals |
| Phone: | 844-366-2424 |
The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of
individuals with Smith-Magenis Syndrome.
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 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
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