Status:
COMPLETED
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Insomnia
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- Subject is male or female 6 to 17 years of age, inclusive, at the time of consent.
- Subject must have a diagnosis of ADHD as defined by DSM-IV criteria
- Subject must have documented 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, (wake time after sleep onset \>45 minutes) despite adequate age appropriate time and opportunity for sleep.
- Subject's Baseline PSG must reveal either \>30 minutes latency to persistent sleep (LPS) or \>45 minutes wake after sleep onset (WASO).
- Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.
- Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time
- Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.(Female subjects ≥8 years of age must have a negative serum pregnancy test)
- Subject must be in general good health
- Subject must be able to swallow tablets.
- If subject is currently taking medication for ADHD, they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent
Exclusion
- Subject with weight \<10th percentile for age and gender
- Subject has any clinically significant or unstable medical illness/abnormality or chronic disease.
- Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis.
- Subject has periodic limb movement \>5 times per hour, as demonstrated on Baseline PSG.
- Subject has sleep disordered breathing, as demonstrated on Baseline PSG.
- Subject has another primary sleep disorder, a secondary sleep disorder, or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
- Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.
- Subject has organic brain disease, or a history of febrile seizures.
- Subject is, in the opinion of the investigator, at suicidal or homicidal risk.
- Female subject who is pregnant or lactating or planning to become pregnant.
- Subject has taken any psychotropic medication without an appropriate washout period (≥5 half-lives) prior to randomization.
- Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
- Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.
- Subject has a history of alcohol or substance abuse within 3 months of study participation.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT00856973
Start Date
May 1 2009
End Date
July 1 2011
Last Update
June 17 2013
Active Locations (73)
Enter a location and click search to find clinical trials sorted by distance.
1
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
2
Dothan Behavioral Medicine Clinic
Dothan, Alabama, United States, 36303
3
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, United States, 85226
4
PsyPharma Clinical Research
Phoenix, Arizona, United States, 85050