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Therapeutic Areas: Neurology | Psychiatry/Psychology
Disease Category: Attention Deficit/Hyperactivity Disorder (ADHD - Adults)

Trial Information

Safety & Efficacy Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder - Associated Insomnia

This is a 12 week study that involves Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment (low versus high dose), and Safety/Efficacy evaluation. This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo.

Patient Inclusion Criteria: Participants can be male or female between the ages of 6 to 17 years. Participants must have a diagnosis of ADHD as defined by DSM-IV criteria and ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency =30 minutes) or consolidation, despite adequate age appropriate time and opportunity for sleep. Participants can be currently taking medication for ADHD, although they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent.

Patient Exclusion Criteria: Participants should be in good health with no comorbid psychiatric conditions.

Lilly Rousseva, CRC
Pacific Institute for Medical Research, Inc
10921 Wilshire Blvd., Ste 702
Los Angeles, CA 90024
Phone: 310/208-7144
Fax: 310/209-0444
EMail: lillyrs@hotmail.com

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