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

Overview

About this study

The primary purpose of this study is to assess the effects of a daily single oral dose of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) in participants over a 28-day period, as measured by sleep diary.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:

- History of psychiatric disorders within 12 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

R Auger, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Deanna Hofschulte CCRP

(507) 255-2972

Hofschulte.Deanna@mayo.edu

More information

Publications

Publications are currently not available
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