Chronobiology Disorders, Gene Mutations and Other Alterations Nec, Sleep Disorders, Circadian Rhythm, Sleep Wake Disorders
Conditions
Brief summary
This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
Interventions
DRUGTasimelteon
Oral capsule
DRUGPlacebo
Oral capsule
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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). * Carrier of CRY1Δ11 variant. * Men or women between 18 - 75 years, inclusive. * Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m\^2.
Exclusion criteria
* 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 |
|---|---|
| Latency to Persistent Sleep, as measured by polysomnography. | Two Nights |
Countries
Turkey (Türkiye)
Contacts
Primary ContactVanda Pharmaceuticals Inc.
Outcome results
None listed