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

Recruiting now · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT06701396

Run by

Vanda Pharmaceuticals

People needed

60

Starts

2024-10-08

Expected to finish

2025-06-30

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Vanda Investigational Site — Çankaya, Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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