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

Vanda Pharmaceuticals (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
300 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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 :
Dec 9, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tasimelteon

Drug: Tasimelteon
oral capsule

Placebo Comparator: Placebo

Drug: Placebo
oral capsule

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy. [28 days]

  2. Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary. [28 days]

  3. Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [28 days]

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 - 75 years, inclusive.

  • Body Mass Index (BMI) of ≥ 18 and ≤ 35 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


Site City State Country Postal Code
1 Vanda Investigational Site Los Angeles California United States 90025
2 Vanda Investigational Site Redwood City California United States 94063
3 Vanda Investigational Site Miami Florida United States 33176
4 Vanda Investigational Site Atlanta Georgia United States 30328
5 Vanda Investigational Site Chicago Illinois United States 60611
6 Vanda Investigational Site Chevy Chase Maryland United States 20815
7 Vanda Investigational Site Boston Massachusetts United States 02115
8 Vanda Investigational Site Rochester Minnesota United States 55905
9 Vanda Investigational Site Durham North Carolina United States 27705
10 Vanda Investigational Site Cincinnati Ohio United States 45212
11 Vanda Investigational Site Cleveland Ohio United States 44195
12 Vanda Investigational Site Danville Pennsylvania United States 17822
13 Vanda Investigational Site Malvern Pennsylvania United States 19355
14 Vanda Investigational Site Columbia South Carolina United States 29201
15 Vanda Investigational Site Austin Texas United States 78731

Sponsors and Collaborators

  • Vanda Pharmaceuticals


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • VP-VEC-162-3502
First Posted:
Dec 3, 2020
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022