Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Condition: Insomnia; Attention Deficit Hyperactivity Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: eszopiclone; eszopiclone; Placebo
Intervention description: 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years; 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years; 1 tablet per day for 12 weeks
Intervention MeSH terms: Eszopiclone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 486.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hypnotic; Eszopiclone; Attention Deficit/Hyperactivity Disorder; Insomnia; Children; Adolescent; Polysomnography; Actigraphy

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.
    

Eligibility 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.