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

Phase 3

Recruiting

• Conditions: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Chronobiology Disorders; Gene Mutations and Other Alterations Nec
• Interventions: Drug: Placebo; Drug: Tasimelteon

• Registration Number: NCT06701396
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-08
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tasimelteon	Tasimelteon	-

Primary Outcome Measures

Name	Time	Method
Latency to Persistent Sleep, as measured by polysomnography.	Two Nights

Trial Locations

Locations (1)

Vanda Investigational Site; 🇹🇷 Çankaya, Ankara, Turkey