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Clinical Trials in Turkey / NCT06701396
Recruiting Phase 3

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

NCT06701396 · tracked via the Priya Life Science Turkey tracker
Sponsor
Vanda Pharmaceuticals
Phase
Phase 3
Started
2024-10-08
Last updated
2024-11-22

Condition(s) studied

Sleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology DisordersGene Mutations and Other Alterations Nec

Investigational drug(s) / intervention(s)

Tasimelteon →Placebo

Tasimelteon: Oral capsule

Placebo: Oral capsule

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Latency to Persistent Sleep, as measured by polysomnography. — Two Nights

Trial sites (1)

FacilityCityRegionStatus
Vanda Investigational Site Çankaya Ankara Recruiting

Other trials for the same condition

Structured Combined Exercise Program in Postmenopausal Women: Effects on Heart Rate Variability and Menopausal Symptoms Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06701396 on ClinicalTrials.gov ↗ ← All trials in Turkey