drugset / Trial / NCT00856973

Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

NCT00856973

Phase 3 Completed 486 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2009-05
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Eszopiclone Small molecule 1 mg Oral
Subject Eszopiclone Small molecule 2 mg Oral
Subject Eszopiclone Small molecule 3 mg Oral