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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

Criteria

Inclusion Criteria:

• Ability and acceptance to provide written informed consent of the participant or legal guardian. Participants ≥ 16 and < 18 years of age will also need to provide written assent.

• A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).

• Men or women between 16 - 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.