Trials / Recruiting
RecruitingNCT06701396
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Vanda Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Sleep Wake Disorders
- Sleep Disorders, Circadian Rhythm
- Chronobiology Disorders
- Gene Mutations and Other Alterations Nec
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tasimelteon | Oral capsule |
| DRUG | Placebo | Oral capsule |
Timeline
- Start date
- 2024-10-08
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2024-11-22
- Last updated
- 2024-11-22
Locations
1 site across 1 country: Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06701396. Inclusion in this directory is not an endorsement.