Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tasimelteon, Placebo.
- Who it may be relevant to
- Registry conditions: Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Tasimelteon
Oral capsule - Drug Placebo
Oral capsule
Primary outcome measures
- Latency to Persistent Sleep, as measured by polysomnography. [Time frame: Two Nights]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Vanda Investigational Site — Çankaya
Identifiers
NCT: NCT06701396 · VP-VEC-162-3501