Status:
COMPLETED
Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Smith-Magenis Syndrome
Circadian
Eligibility:
All Genders
3-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.
Eligibility Criteria
Inclusion
- A confirmed clinical diagnosis of SMS
- Informed consent from the patient or the legal guardian
- Male or female between the ages of 3- 65 years of age
- Recent history of sleep disturbances
- Have an appointed care-giver complete the required outpatient assessments
- Willing and able to comply with study requirements and restrictions
Exclusion
- Unable to dose daily with medication
- Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening
- Any other sound medical reason as determined by the clinical investigator
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02231008
Start Date
September 1 2015
End Date
January 1 2022
Last Update
November 18 2022
Active Locations (4)
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1
Santa Monica, California, United States
2
Baltimore, Maryland, United States
3
Chevy Chase, Maryland, United States
4
Houston, Texas, United States