RecruitingPhase 3NCT06701396

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

A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

Sponsor

Vanda Pharmaceuticals

Enrollment

60 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria4

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.

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