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

Vanda Pharmaceuticals49 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Smith-Magenis Syndrome Circadian

Interventions

tasimelteonDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Santa Monica, California, United States

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

Chevy Chase, Maryland, United States

Unnamed facility

Houston, Texas, United States

Outcomes

Primary Outcomes

To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters

Time frame: 9 Weeks

Secondary Outcomes

Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).

Time frame: up to 137 weeks

Data from ClinicalTrials.gov

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