Chronobiology Disorders, Sleep Disorders, Circadian Rhythm, Sleep Wake Disorders
Conditions
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.
Interventions
DRUGTasimelteon
oral capsule
DRUGPlacebo
oral capsule
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Sleep Onset over the treatment period, as measured by sleep diary. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, Germany, United States
Outcome results
None listed