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New treatment option for Sleep Wake Disorders
Official title Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
ClinicalTrials.gov ID: NCT06701396
What this study is testing
What is Tasimelteon?
Tasimelteon is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sleep wake disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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 likely can't join 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.
The study team makes the final eligibility decision.
Where it's taking place
- Çankaya, Ankara, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Çankaya, Ankara, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.