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

Trial Information

Children with ADHD and Insomnia

Safety, Tolerability Evaluation of Single Oral Doses of Eszopiclone in Children 6 to 11 Years of Age and Adolescents 12 to 17 years of age with Attention Deficit Hyperactivity Disorder and Insomnia

Patient Inclusion Criteria Parent or Guardian willing and able to give written informed consent, subject's parent or guardian willing and able to comply with procedures, visit schedules and overnight stays. Subject between the ages of 6 to 11, or 12 to 17 at the time of consent. Subject must have documented diagnosis of ADHD, and subject or parent/guardian must report repeated difficulty with sleep initiation at least 3 times a week over the past three months. Daytime functional impairment as a result of sleep problems. Subject must be on stable does of ADHD medication for at least 1 month prior to screening. Age appropriate females must have negative pregnancy test at time of screening. All subject must be in general good health.

Patient Exclusion Criteria
Subject weighs less than 30 kg (66 lbs.)at study entry. Subject has documented history of Bipolar I or II Disorder, major depression, generalized anxiety disorder or history of any psychosis. Taken any antipsychotic drugs within 8 weeks of screening. Has another primary sleep disorder. Subject has history of severe allergies to more than one class of medications. Subject is not in general good health.

Janis Mann, Clinical Research Coordinator
Gulf Coast Research Associates, Inc.
7049 Perkins Road
Baton Rouge, LA 70808
Phone: 225-757-1084
Fax: 225-757-0294
EMail: janis@gulfcoastra.com

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