CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
tasimelteon +1 moredrug
Likely dose
tasimelteon 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01430754
NCT01430754Phase 3Completed
CompareCT.gov

A Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD

Vanda Pharmaceuticals·interventional·Posted Sep 8, 2011·Updated Oct 10, 2014

In Brief

A Phase 3 clinical trial evaluating tasimelteon and Placebo for Non-24-Hour Sleep-Wake Disorder. Completed, enrolled 20 participants across 22 sites.

Detailed Summary

The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-24-Hour Sleep-Wake Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 8, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

tasimelteondrug

20 mg tasimelteon capsules, daily

Placebodrug

Placebo capsules, daily