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

NCT06701396 — Phase 3, Recruiting, 60 participants, Vanda Pharmaceuticals

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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

Registry	NCT06701396
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	60 (Estimated)
Sponsor	Vanda Pharmaceuticals (Industry)
Conditions	Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec
Interventions	Tasimelteon, Placebo (Drug)
Dates	start 2024-10-08, primary completion 2025-06-30 (estimated), completion 2025-06-30 (estimated), first posted 2024-11-22, last updated 2024-11-22
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Tasimelteon	Experimental	Drug: Tasimelteon
Placebo	Placebo comparator	Drug: Placebo

Tasimelteon (Drug): Oral capsule
Placebo (Drug): Oral capsule

+Outcome measures

Primary outcomes

Latency to Persistent Sleep, as measured by polysomnography. [Two Nights]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (1)

Facility	City	Country	Status
Vanda Investigational Site	Çankaya, Ankara	Turkey (Türkiye)	Recruiting

My Notes

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