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

Sleep Disorders, Circadian Rhythm Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04652882
• Other study ID #: VP-VEC-162-3502
• Status: Recruiting
• Phase: Phase 3
• Start date: December 9, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmaceuticals Inc.
• Phone: 202-734-3400
• Email: VEC162[@]vandapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

• Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tasimelteon
oral capsule
• Placebo
oral capsule

Locations

Country	Name	City	State
Australia	Vanda Investigational Site	Glebe	New South Wales
Germany	Vanda Investigational Site	Berlin
Germany	Vanda Investigational Site	Hamburg
Germany	Vanda Investigational Site	München
Germany	Vanda Investigational Site	Schwerin
United States	Vanda Investigational Site	Austin	Texas
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Chicago	Illinois
United States	Vanda Investigational Site	Cincinnati	Ohio
United States	Vanda Investigational Site	Cleveland	Ohio
United States	Vanda Investigational Site	Columbia	South Carolina
United States	Vanda Investigational Site	Los Angeles	California
United States	Vanda Investigational Site	McKinney	Texas
United States	Vanda Investigational Site	Miami	Florida
United States	Vanda Investigational Site	Redwood City	California
United States	Vanda Investigational Site	Rochester	Minnesota
United States	Vanda Investigational Site	Saint Louis	Missouri
United States	Vanda Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Onset over the treatment period, as measured by sleep diary.		28 days
Secondary	Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.		28 days
Secondary	Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.		28 days
Secondary	Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).		28 days