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

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04652882

Collaborator

(none)

300

Enrollment

Locations

Arms

35.7

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

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
Sleep Wake Disorders Sleep Disorders, Circadian Rhythm Chronobiology Disorders	Drug: Tasimelteon Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated 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 :

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

Arm

Intervention/Treatment

Experimental: Tasimelteon

Drug: Tasimelteon

oral capsule

Placebo Comparator: Placebo

Drug: Placebo

oral capsule

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vanda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04652882

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:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Wake Disorders

Sleep Disorders, Circadian Rhythm

Chronobiology Disorders

Disease

Study Results

No Results Posted as of Jan 14, 2022