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RECRUITING
NCT06701396
PHASE3

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

Sponsor: Vanda Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-08

Completion Date

2025-06-30

Last Updated

2024-11-22

Healthy Volunteers

No

Interventions

DRUG

Tasimelteon

Oral capsule

DRUG

Placebo

Oral capsule

Locations (1)

Vanda Investigational Site

Çankaya, Ankara, Turkey (Türkiye)