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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02231008
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : November 18, 2022
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Smith-Magenis Syndrome Circadian Drug: tasimelteon Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 2015
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tasimelteon

Arm Intervention/treatment
Experimental: Tasimelteon
Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage
Drug: tasimelteon
Placebo Comparator: Placebo
Placebo comparator
Drug: placebo

Primary Outcome Measures :
  1. To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters [ Time Frame: 9 Weeks ]

Secondary Outcome Measures :
  1. Safety and tolerability as measured by spontaneous reporting of adverse events (AEs). [ Time Frame: up to 137 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231008

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United States, California
Santa Monica, California, United States
United States, Maryland
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02231008    
Other Study ID Numbers: VP-VEC-162-2401
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 2022
Keywords provided by Vanda Pharmaceuticals:
Additional relevant MeSH terms:
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Smith-Magenis Syndrome
Pathologic Processes
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Chronobiology Disorders
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn