CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 320 enrolled
Drug / intervention
Tasimelteon +1 moredrug
Likely dose
Tasimelteon oral capsule (specific dose not stated)AI-extracted
Key inclusion· 4
  • ✓Age 18-75 years
  • ✓Healthy with no medical, psychiatric, or current sleep disorders
  • ✓Body Mass Index 18-30 kg/m²
  • ✓Able to provide written informed consent and fluent in English
Key exclusion· 3
  • ✕Major surgery, trauma, illness, or immobility for 3+ days in the past month
  • ✕Pregnancy or pregnancy within 6 weeks
  • ✕Positive drug screening test

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03373201
NCT03373201Phase 3Completed
CompareCT.gov

Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

Vanda Pharmaceuticals·interventional·Posted Dec 14, 2017·Updated Sep 15, 2023

In Brief

A Phase 3 clinical trial evaluating Tasimelteon and Placebo for Jet Lag Type Insomnia. Completed, enrolled 320 participants across 12 sites.

Detailed Summary

The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJet Lag Type Insomnia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 14, 2017
Enrollment StartOct 16, 2017
Primary CompletionMar 5, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.5 years ago

Interventions

Tasimelteondrug

Oral capsule

Placebodrug

Oral capsule