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

A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.

Study Overview

• Status: Recruiting
• Conditions: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Chronobiology Disorders; Gene Mutations and Other Alterations Nec
• Intervention / Treatment: Drug: Placebo; Drug: Tasimelteon

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Vanda Pharmaceuticals Inc.; Phone Number: 202-734-3400; Email: VEC162@vandapharma.com

Study Locations

• Turkey
  • Ankara
    • Çankaya, Ankara, Turkey, 06800
      • Recruiting
      • Vanda Investigational Site
      • Contact: Vanda Pharmaceuticals Inc.; Phone Number: 202-734-3400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral capsule
Experimental: Tasimelteon	Drug: Tasimelteon; Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Latency to Persistent Sleep, as measured by polysomnography.	Two Nights

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Dyssomnias; Occupational Diseases; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Chronobiology Disorders
• Other Study ID Numbers: VP-VEC-162-3501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No