At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 132 enrolled
Drug / intervention
Ramelteon +3 moredrug
Likely dose
Ramelteon 1 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 Randomized, Double-Blind, Placebo-Controlled, Parallel, Proof of Concept Study to Evaluate the Effectiveness of Ramelteon to Advance the Timing of Sleep in Individuals With Delayed Sleep Phase Syndrome (DSPS)
In Brief
A Phase 2 clinical trial evaluating Ramelteon and Placebo for Sleep Disorders, Circadian Rhythm. Completed, enrolled 132 participants across 42 sites.
Detailed Summary
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Disorders, Circadian Rhythm
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedJan 2008
Primary CompletionMay 2008
TodayJul 2026
First PostedJan 15, 2008
Enrollment StartOct 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.5 years ago
Interventions
Ramelteondrug
Ramelteon 1 mg, tablets, orally, once daily for up to two weeks.
Ramelteondrug
Ramelteon 4 mg, tablets, orally, once daily for up to two weeks.
Ramelteondrug
Ramelteon 8 mg, tablets, orally, once daily for up to two weeks.
Placebodrug
Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.