At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 12 enrolled
Drug / intervention
Ramelteon +1 moredrug
Likely dose
Ramelteon 8 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.
Melatonin Replacement for Treatment of Sleep Disruption
In Brief
A Phase 4 clinical trial evaluating Ramelteon and Placebo for Insomnia and 3 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Spinal Cord Injury, Tetraplegia, Sleep Disorders
CountriesUnited States
CollaboratorsStanford University, Takeda
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedJul 2007
Primary CompletionDec 2010
Study CompletionJul 2011
TodayJul 2026
First PostedJul 26, 2007
Enrollment StartJul 1, 2007
Primary CompletionDec 1, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.9 years ago
Interventions
Ramelteondrug
8 mg nightly
Placebodrug
Nightly 8mg of placebo (same appearance as ramelteon)