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

Primary Purpose

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

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tasimelteon
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Wake Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tasimelteon

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Sleep Onset over the treatment period, as measured by sleep diary.

Secondary Outcome Measures

Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.
Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).

Full Information

First Posted
November 19, 2020
Last Updated
January 12, 2022
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04652882
Brief Title
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tasimelteon
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tasimelteon
Intervention Description
oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsule
Primary Outcome Measure Information:
Title
Change in Sleep Onset over the treatment period, as measured by sleep diary.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.
Time Frame
28 days
Title
Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.
Time Frame
28 days
Title
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Email
VEC162@vandapharma.com
Facility Information:
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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