At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 136 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.
A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon Versus Placebo in Totally Blind Subjects With N24HSWD Followed by an OLE Phase
In Brief
A Phase 3 clinical trial evaluating tasimelteon and Placebo for Non-24-Hour Sleep-Wake Disorder. Completed, enrolled 136 participants across 28 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-24-Hour Sleep-Wake Disorder
CountriesGermany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartAug 2010
Primary CompletionNov 2012
TodayJul 2026
First PostedJul 15, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.0 years ago
Interventions
tasimelteondrug
20 mg tasimelteon capsules, PO daily for 6 months
Placebodrug
Placebo capsules, PO daily for 6 months