Clinical trial NCT04652882: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

* 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.
* Current tobacco user.

Primary outcomes:
measure: Change in Sleep Onset over the treatment period, as measured by sleep diary.
timeFrame: 28 days
Secondary outcomes:
measure: Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.
timeFrame: 28 days
measure: Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.
timeFrame: 28 days
measure: Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
timeFrame: 28 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: Redwood City
country: United States
facility: Vanda Investigational Site
state: California
city: Aurora
country: United States
facility: Vanda Investigational Site
state: Colorado
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Boston
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: Vanda Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Vanda Investigational Site
state: Missouri
city: New Hyde Park
country: United States
facility: Vanda Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Columbia
country: United States
facility: Vanda Investigational Site
state: South Carolina
city: McKinney
country: United States
facility: Vanda Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Vanda Investigational Site
state: Texas
city: Innsbruck
country: Austria
facility: Vanda Investigational Site
city: Linz
country: Austria
facility: Vanda Investigational Site
city: Vienna
country: Austria
facility: Vanda Investigational Site
city: Berlin
country: Germany
facility: Vanda Investigational Site
city: Hamburg
country: Germany
facility: Vanda Investigational Site
city: Marburg
country: Germany
facility: Vanda Investigational Site
city: Munich
country: Germany
facility: Vanda Investigational Site
city: Schwerin
country: Germany
facility: Vanda Investigational Site
Study officials:
References: