Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

ConditionsSleep Wake Disorders Sleep Disorders, Circadian Rhythm Chronobiology Disorders Gene Mutations and Other Alterations Nec

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorVanda Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

Tasimelteon
Placebo

Treatment groups

60 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Vanda Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov