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Trial record 83 of 669 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT02231008
Recruitment Status : Unknown
Verified May 2016 by Vanda Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : September 3, 2014
Last Update Posted : May 16, 2016
Sponsor:
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 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2015
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tasimelteon

Arm Intervention/treatment
Experimental: Tasimelteon
Single dose oral capsule, daily dosage, for 21 weeks
Drug: tasimelteon
Placebo Comparator: Placebo
Placebo comparator
Drug: tasimelteon



Primary Outcome Measures :
  1. To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters [ Time Frame: 21 Weeks ]
  2. Clinical Global Impression - Severity scale (CGI-S) [ Time Frame: 21 Weeks ]
    To characterize the effects of an investigational treatment regimen on the circadian rhythms of individuals with SMS as measured by biomarkers



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Contacts
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Contact: Vanda Pharmaceuticals 844-366-2424

Locations
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United States, California
Santa Monica Clinical Trials Recruiting
Santa Monica, California, United States, 90404
Contact: Kerri       kcali@smclinicaltrials.com   
United States, Maryland
The Center for Sleep & Wake Disorders Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Jaime       sleepdoc@sleepdoc.com   
United States, Texas
Baylor Clinic Recruiting
Houston, Texas, United States, 77030
Contact: Zohra       Zohra.Huda@bcm.edu   
Sponsors and Collaborators
Vanda Pharmaceuticals

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02231008     History of Changes
Other Study ID Numbers: VP-VEC-162-2401
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Vanda Pharmaceuticals:
SMS
Additional relevant MeSH terms:
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Smith-Magenis Syndrome
Chronobiology Disorders
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn