Evaluating Tasimelteon for Delayed Sleep-Wake Phase Disorder
A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
This study is testing if a daily pill called tasimelteon can help people with Delayed Sleep-Wake Phase Disorder get better sleep compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Trial ID | NCT04652882 on ClinicalTrials.gov |
What this trial studies
This multicenter, double-blind, randomized study aims to assess the efficacy and safety of a daily oral dose of tasimelteon compared to a placebo in individuals diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD). Participants will be randomly assigned to receive either the medication or a matching placebo, and their sleep patterns will be monitored throughout the study. The trial includes both male and female participants aged 18 to 75 with a confirmed diagnosis of DSWPD. The study seeks to provide insights into how tasimelteon can help regulate sleep-wake cycles in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 75 with a confirmed diagnosis of Delayed Sleep-Wake Phase Disorder.
Not a fit: Patients with exacerbated psychiatric conditions, recent major surgeries, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and daily functioning for patients with DSWPD.
How similar studies have performed: Previous studies have shown promise in using melatonin receptor agonists for sleep disorders, suggesting potential success for this approach.
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). * Men or women between 18 - 75 years, inclusive. * Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m\^2. Exclusion Criteria: * Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months. * 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
Los Angeles, California and 16 other locations
- Vanda Investigational Site — Los Angeles, California, United States (Recruiting)
- Vanda Investigational Site — Redwood City, California, United States (Recruiting)
- Vanda Investigational Site — Aurora, Colorado, United States (Recruiting)
- Vanda Investigational Site — Boston, Massachusetts, United States (Recruiting)
- Vanda Investigational Site — St Louis, Missouri, United States (Recruiting)
- Vanda Investigational Site — New Hyde Park, New York, United States (Recruiting)
- Vanda Investigational Site — Cincinnati, Ohio, United States (Recruiting)
- Vanda Investigational Site — Cleveland, Ohio, United States (Recruiting)
- Vanda Investigational Site — Columbia, South Carolina, United States (Recruiting)
- Vanda Investigational Site — San Antonio, Texas, United States (Recruiting)
- Vanda Investigational Site — Sherman, Texas, United States (Recruiting)
- Vanda Investigational Site — Innsbruck, Austria (Active_not_recruiting)
- Vanda Investigational Site — Vienna, Austria (Recruiting)
- Vanda Investigational Site — Berlin, Germany (Recruiting)
- Vanda Investigational Site — Hamburg, Germany (Recruiting)
- Vanda Investigational Site — Marburg, Germany (Recruiting)
- Vanda Investigational Site — Schwerin, Germany (Recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals Inc.
- Email: clinicaltrials@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.