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Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)

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ClinicalTrials.gov Identifier: NCT04652882
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Study Description
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Brief Summary:
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.

Condition or disease Intervention/treatment Phase
Sleep Wake Disorders Sleep Disorders, Circadian Rhythm Chronobiology Disorders Drug: Tasimelteon Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tasimelteon

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tasimelteon Drug: Tasimelteon
oral capsule
Placebo Comparator: Placebo Drug: Placebo
oral capsule


Outcome Measures
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Primary Outcome Measures :
  1. Change in Sleep Onset over the treatment period, as measured by sleep diary. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy. [ Time Frame: 28 days ]
  2. Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary. [ Time Frame: 28 days ]
  3. Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [ Time Frame: 28 days ]

Eligibility Criteria
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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:

  • Ability and acceptance to provide written informed consent of the participant or legal guardian. Participants ≥ 16 and < 18 years of age will also need to provide written assent.
  • A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
  • Men or women between 16 - 65 years, inclusive.
  • Body Mass Index (BMI) of ≥ 18 and ≤ 30 kg/m^2.

Exclusion Criteria:

  • History of psychiatric disorders within 12 months.
  • Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
  • Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
  • A positive test for substances of abuse.
Contacts and Locations
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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): NCT04652882


Contacts
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Contact: Vanda Pharmaceuticals Inc. 202-734-3400 VEC162@vandapharma.com

Locations
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United States, California
Vanda Investigational Site Recruiting
Redwood City, California, United States, 94063
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
Vanda Investigational Site Recruiting
Santa Monica, California, United States, 90404
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Georgia
Vanda Investigational Site Recruiting
Atlanta, Georgia, United States, 30328
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Illinois
Vanda Investigational Site Recruiting
Chicago, Illinois, United States, 60611
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Maryland
Vanda Investigational Site Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Massachusetts
Vanda Investigational Site Recruiting
Boston, Massachusetts, United States, 02115
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Ohio
Vanda Investigational Site Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Oregon
Vanda Investigational Site Recruiting
Portland, Oregon, United States, 97214
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Pennsylvania
Vanda Investigational Site Recruiting
Malvern, Pennsylvania, United States, 19355
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, South Carolina
Vanda Investigational Site Recruiting
Columbia, South Carolina, United States, 29201
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Texas
Vanda Investigational Site Recruiting
Austin, Texas, United States, 78731
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals
More Information
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04652882    
Other Study ID Numbers: VP-VEC-162-3502
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Disease
Pathologic Processes
 Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Dyssomnias
Occupational Diseases