Trial Profile
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
Status:
Recruiting
Phase of Trial:
Phase III
Latest Information Update: 06 Nov 2019
Price :
$35
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At a glance
- Drugs Tasimelteon (Primary)
- Indications Circadian rhythm sleep disorders
- Focus Adverse reactions; Registrational
- Sponsors Vanda Pharmaceuticals
- 14 Nov 2017 Planned primary completion date changed from 1 Dec 2017 to 1 Dec 2018.
- 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.