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

Launched by VANDA PHARMACEUTICALS · Dec 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tasimelteon to see if it can help people with Delayed Sleep-Wake Phase Disorder (DSWPD), a condition where individuals have trouble sleeping and waking at typical times. The study is being conducted at multiple locations and involves giving participants either tasimelteon or a placebo (a pill that looks the same but has no active medication) once a day. Researchers want to find out how well tasimelteon works and if it is safe for people with this sleep disorder.

To participate, individuals need to be between 18 and 75 years old and must have a confirmed diagnosis of DSWPD. They should also be generally healthy without certain recent medical issues, like major surgery or substance abuse. Participants will be asked to provide informed consent and will be closely monitored throughout the trial. This study aims to improve understanding of DSWPD and potentially offer new treatment options for those affected by it.

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).
• • 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.