At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 486 enrolled
Drug / intervention
eszopiclone +2 moredrug
Likely dose
eszopiclone 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, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
In Brief
A Phase 3 clinical trial evaluating eszopiclone and Placebo for Insomnia and Attention Deficit Hyperactivity Disorder. Completed, enrolled 486 participants across 73 sites.
Detailed Summary
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Attention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartMay 2009
Primary CompletionJul 2011
TodayJul 2026
First PostedMar 6, 2009
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.3 years ago
Interventions
eszopiclonedrug
1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
eszopiclonedrug
2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Placebodrug
1 tablet per day for 12 weeks