Evaluating Tasimelteon for Delayed Sleep-Wake Phase Disorder
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
This study is testing if a new sleep medication called tasimelteon can help people with Delayed Sleep-Wake Phase Disorder who have a specific genetic variant improve their sleep patterns.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Çankaya, Ankara) |
| Trial ID | NCT06701396 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind, randomized, two-period crossover study designed to assess the efficacy and safety of a single oral dose of tasimelteon compared to a placebo in individuals diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD) who also carry the CRY1Δ11 genetic variant. Participants will be monitored for improvements in their sleep patterns and overall circadian rhythm. The study aims to gather data on how tasimelteon affects sleep-wake cycles in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 18 to 75 with a confirmed diagnosis of DSWPD and who are carriers of the CRY1Δ11 variant.
Not a fit: Patients who have had major surgery, trauma, or illness in the past 30 days, or who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from DSWPD, potentially improving their quality of life.
How similar studies have performed: Other studies have explored treatments for sleep disorders, but the specific approach of using tasimelteon in this genetic context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Çankaya, Ankara
- Vanda Investigational Site — Çankaya, Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals Inc.
- Email: VEC162@vandapharma.com
- Phone: 202-734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.