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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Tasimelteon
Drug
Oral capsule
Placebo
Drug
Oral capsule

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: TasimelteonExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Latency to Persistent Sleep, as measured by polysomnography.

Time frame

Two Nights

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanda Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

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