Open-Label Safety Study of a 1-Year 20 mg Dose Regimen of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder (N24HSWD) in Blind Individuals With No Light Perception.
Phase of Trial: Phase III
Latest Information Update: 23 Jun 2016
At a glance
- Drugs Tasimelteon (Primary)
- Indications Circadian rhythm sleep disorders
- Focus Adverse reactions; Registrational
- Sponsors Vanda Pharmaceuticals
- 10 Jun 2016 Planned primary completion date changed from 1 Sep 2015 to 1 Dec 2017.
- 24 Apr 2015 According to a Vanda Pharmaceuticals media release, the EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of tasimelteon (HETLIOZ) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
- 06 Jan 2015 According to the ClinicalTrials.gov record, planned end date changed from 1 Sep 2014 to 1 Sep 2015.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History