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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 : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 19, 2020
First Posted Date  ICMJE December 3, 2020
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
Change in Sleep Onset over the treatment period, as measured by sleep diary. [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
  • Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy. [ Time Frame: 28 days ]
  • Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary. [ Time Frame: 28 days ]
  • Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Official Title  ICMJE A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Wake Disorders
  • Sleep Disorders, Circadian Rhythm
  • Chronobiology Disorders
Intervention  ICMJE
  • Drug: Tasimelteon
    oral capsule
  • Drug: Placebo
    oral capsule
Study Arms  ICMJE
  • Experimental: Tasimelteon
    Intervention: Drug: Tasimelteon
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability and acceptance to provide written informed consent.
  • A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
  • Men or women between 18 - 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vanda Pharmaceuticals Inc. 202-734-3400 VEC162@vandapharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04652882
Other Study ID Numbers  ICMJE VP-VEC-162-3502
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vanda Pharmaceuticals
Study Sponsor  ICMJE Vanda Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanda Pharmaceuticals
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP