Evaluating Tasimelteon for Delayed Sleep-Wake Phase Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a double-blind, randomized, two-period crossover study designed to assess the efficacy and safety of a single oral dose of tasimelteon compared to a placebo in individuals diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD) who also carry the CRY1Δ11 genetic variant. Participants will be monitored for improvements in their sleep patterns and overall circadian rhythm. The study aims to gather data on how tasimelteon affects sleep-wake cycles in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vanda Investigational Site
  Çankaya, Ankara, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Vanda Pharmaceuticals Inc.
• Email: VEC162@vandapharma.com
• Phone: 202-734-3400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.