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

Launched by VANDA PHARMACEUTICALS · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tasimelteon to see how well it helps people with Delayed Sleep-Wake Phase Disorder (DSWPD), a condition where a person's sleep schedule is significantly delayed compared to the normal pattern. The trial specifically focuses on individuals who carry a genetic variant known as CRY1Δ11. Participants will receive either tasimelteon or a placebo (a sugar pill with no active medication) to compare the effects. The study is designed to be fair, meaning neither the participants nor the researchers will know who is receiving which treatment at first.

To join the study, participants must be between 18 and 75 years old and have a confirmed diagnosis of DSWPD along with the CRY1Δ11 variant. They should also be in good health without recent major health issues, and they cannot be pregnant or breastfeeding. If eligible, participants can expect to take the medication in a controlled setting and help researchers understand its effectiveness and safety. This trial is currently recruiting, so it's a good opportunity for those who meet the criteria and are looking for ways to manage their sleep issues.

Gender

ALL

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.