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

Phase 3

Recruiting

• Conditions: Sleep Disorders, Circadian Rhythm; Chronobiology Disorders; Sleep Wake Disorders
• Interventions: Drug: Tasimelteon; Drug: Placebo

• Registration Number: NCT04652882
• Lead Sponsor: Vanda Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Study Start: 2020-12-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tasimelteon	Tasimelteon	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Sleep Onset over the treatment period, as measured by sleep diary.	28 days

Secondary Outcome Measures

Name	Time	Method
Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.	28 days
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).	28 days
Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.	28 days

Trial Locations

Locations (1)

Vanda Investigational Site; 🇩🇪 Schwerin, Germany