Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS
Phase 2
Completed
- Conditions
- Smith-Magenis SyndromeCircadian
- Interventions
- Drug: tasimelteonDrug: placebo
- Registration Number
- NCT02231008
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief Summary
The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
- 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
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tasimelteon tasimelteon Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage Placebo placebo Placebo comparator
- Primary Outcome Measures
Name Time Method To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters 9 Weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerability as measured by spontaneous reporting of adverse events (AEs). up to 137 weeks