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NCT Number: NCT06701396

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

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.

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Key information

Conditions

Sleep Wake Disorders Chronobiology Disorders Dyssomnias Gene Mutations and Other Alterations Nec Mental Disorders Nervous System Diseases Neurologic Manifestations Occupational Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Circadian Rhythm

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site

Çankaya, Ankara, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Vanda Pharmaceuticals Inc.

CONTACT

202-734-3400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tasimelteon

Drug

Oral capsule

Placebo

Drug

Oral capsule

Primary outcomes

  1. Latency to Persistent Sleep, as measured by polysomnography.

    Time frame: Two Nights

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals Inc.

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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