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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Vanda Pharmaceuticals
Study ID
NCT04652882
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronobiology Disorders
  • Sleep Disorders, Circadian Rhythm
  • Sleep Wake Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tasimelteon — DRUG
    oral capsule
  • Placebo — DRUG
    oral capsule

Study Details

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.

Key Dates

Start date
Dec 9, 2020
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tasimelteon
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Vanda Investigational SiteLos AngelesCalifornia90025
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteRedwood CityCalifornia94063
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteAuroraColorado80045
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteBostonMassachusetts02115
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteSt LouisMissouri63123
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteNew Hyde ParkNew York11042
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteCincinnatiOhio45212
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteClevelandOhio44195
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteColumbiaSouth Carolina29201
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteSan AntonioTexas78229
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteShermanTexas75092
Vanda Pharmaceuticals Inc.
202-734-3400

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Vanda Investigational Site· Los Angeles, CAVanda Investigational Site· Redwood City, CAVanda Investigational Site· Aurora, COVanda Investigational Site· Boston, MAVanda Investigational Site· St Louis, MOVanda Investigational Site· New Hyde Park, NY

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