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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Eszopiclone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.