CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 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.

Search/NCT00622427
NCT00622427Phase 4Completed
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Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

University of Alabama at Birmingham·interventional·Posted Feb 25, 2008·Updated May 24, 2013

In Brief

A Phase 4 clinical trial evaluating Ramelteon and Placebo for ADHD With Sleep Onset Insomnia. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD With Sleep Onset Insomnia
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2008
Enrollment StartFeb 1, 2008
Primary CompletionFeb 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.4 years ago

Interventions

Ramelteondrug

8 mg tablets every night for 2 weeks

Placebodrug

placebo tablets for every night for 2 weeks