At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
Ramelteondrug
Likely dose
Not stated in 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 Comparative Single Dose Pharmacokinetic and Safety Study of 4 mg or 8 mg Ramelteon in Adolescents With Insomnia Characterized by Difficulty With Sleep Onset, Children With Insomnia Associated With ADHD, and Healthy Adults.
In Brief
A Phase 1 clinical trial evaluating Ramelteon for Insomnia. Completed, enrolled 56 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartNov 2009
Primary CompletionMar 2011
Study CompletionApr 2011
TodayJul 2026
First PostedJun 5, 2009
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.1 years ago
Interventions
Ramelteondrug
Ramelteon tablets, orally for one day only.