NCT06701396

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

November 14, 2024

Last Update Submit

November 19, 2024

Conditions

Sleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology DisordersGene Mutations and Other Alterations Nec

Outcome Measures

Primary Outcomes (1)

  • Latency to Persistent Sleep, as measured by polysomnography.

    Two Nights

Study Arms (2)

Tasimelteon

EXPERIMENTAL
Drug: Tasimelteon

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TasimelteonDRUG

Oral capsule

Tasimelteon
PlaceboDRUG

Oral capsule

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanda Investigational Site

Çankaya, Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology Disorders

Interventions

tasimelteon

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDyssomniasOccupational Diseases

Central Study Contacts

Vanda Pharmaceuticals Inc.

CONTACT

202-734-3400VEC162@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 22, 2024

Study Start

October 8, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)