At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 322 enrolled
Drug / intervention
VEC-162 20 mg +2 moredrug
Likely dose
VEC-162 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-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia
In Brief
A Phase 3 clinical trial evaluating VEC-162 20 mg, Placebo, and 1 other intervention for Primary Insomnia. Completed, enrolled 322 participants across 35 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Insomnia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartNov 2007
Primary CompletionFeb 2008
Study CompletionJun 2008
TodayJul 2026
First PostedOct 23, 2007
Enrollment StartNov 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.7 years ago
Interventions
VEC-162 20 mgdrug
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Placebodrug
Placebo capsules, PO daily for five weeks
VEC-162 50 mgdrug
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks