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

Completed · Phase 3 · Has a placebo group

Conditions studied: Insomnia, Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT00856973

Run by

Sumitomo Pharma America, Inc.

People needed

486

Starts

2009-05-01

Expected to finish

2011-07-01

Last updated by the study team

2013-06-17

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Dothan Behavioral Medicine Clinic — Dothan, Alabama, United States
• Metropolitan Neuro Behavioral Institute — Chandler, Arizona, United States
• PsyPharma Clinical Research — Phoenix, Arizona, United States
• REM Medical Clinical Research — Tucson, Arizona, United States
• Paul E. Wylie — Little Rock, Arkansas, United States
• AV Institute, Inc. — Carson, California, United States
• Clinical Innovations, Inc. — Costa Mesa, California, United States
• Avastra Clinical Trials — Fountain Valley, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Pacific Institute for Medical Research Inc — Los Angeles, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• North County Clinical Research (NCCR) — Oceanside, California, United States
• Pacific Clinical Research Medical Group — Orange, California, United States
• SDS Clinical Trials — Orange, California, United States
• California Clinical Trials Medical Group — Paramount, California, United States
• Clinical Innovations, Inc. — Riverside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Clinical Innovations, Inc. — San Diego, California, United States
• Neuropsychiatric Research Center of Orange County — Santa Ana, California, United States
• Clinical Innovations, Inc. — Santa Ana, California, United States
• Elite Clinical Trials — Wildomar, California, United States
• Delta Waves, INC — Colorado Springs, Colorado, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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