Safety & Efficacy Study in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia - Full Text View

Sponsor:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00856973

Purpose

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.

Condition	Intervention	Phase
Insomnia Attention Deficit Hyperactivity Disorder	Drug: eszopiclone Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

Change from Polysomnography (PSG) Baseline to the end of the double blind treatment period in PSG defined Latency to Persistent Sleep (LPS). [ Time Frame: Day -14 to -7, week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to each post baseline study visit in subjective Latency to Persitent Sleep (LPS) [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change from PSG Baseline to the end of the double blind treatment period in PSG defined Wake Time After Sleep Onset (WASO). [ Time Frame: Day-14 to -7, week 12 ] [ Designated as safety issue: No ]
Change from baseline (Day 0) to each post baseline study visit in subjective WASO [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change from baseline to each post baseline study visit in Clinical Global Improvement (CGI)-Parent/Caregiver [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change from baseline to each post baseline study visit in CGI-Child [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change from baseline (Day 0) to each post baseline study visit in Conners' ADHD rating scale. [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change from PSG Baseline to the end of the double blind treatment period in PSG defined sleep efficiency [ Time Frame: Day-14 to -7, week 12 ] [ Designated as safety issue: No ]
Change from PSG Baseline to the end of double blind treatment period in PSG defined Number of Awakenings After Sleep Onset(NAASO). [ Time Frame: Day-14 to -7, week 12 ] [ Designated as safety issue: No ]
Change from PSG Baseline to the end of the double blind treatment period in PSG defined Total Sleep Time (TST) [ Time Frame: Day-14 to -7, week 12 ] [ Designated as safety issue: No ]
Change from baseline (Day 0) to each post baseline study visit in subjective TST. [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change in LPS, TST, WASO, and NAASO measured by actigraphy monitoring in the actigraphy subset of subjects from the 7 day period beginning after PSG Baseline to the 7 day periods beginning after Visits 3, 5, and 6 [ Time Frame: Day-14 to -7, Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change in behavioral variables (as assessed by Pediatric Daytime Sleepiness Scale, Child Behavior Checklist, and Pediatric Quality of Life Scale [Short Form 10]) from baseline (Day 0) to each post baseline study visit [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 85, day 98 ] [ Designated as safety issue: No ]
Change from baseline (Day 0) to each post baseline study visit in Conners' ADHD rating scale [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change in cognition variables (as assessed by Conners' Continuous Performance Test II and Coding Copy Subtest A or B, or DSST scaled score, as appropriate for subject age) from baseline (Day 0) to each post baseline study visit [ Time Frame: Day 0, day 14, day 42, day 70, day 84, day 98 ] [ Designated as safety issue: No ]
Change in school tardiness/attendance reports from Day 0 to Visits 5, 7, and 8. [ Time Frame: Day 0, day 42, day 84, day 98 ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	May 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low dose eszopiclone: Experimental 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Drug: eszopiclone one 1 mg tablet per day for 12 weeks Drug: eszopiclone one 2 mg tablet per day for 12 weeks
High dose eszopiclone: Experimental 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Drug: eszopiclone one 2 mg tablet per day for 12 weeks
Placebo: Placebo Comparator Placebo 6-17 years	Drug: Placebo 1 tablet per day for 12 weeks

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 be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, 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)
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.
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 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.
Subject taking any psychotropic medication or disallowed medications for chronic treatment
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856973

Contacts

Contact: Central Contact

1-866-503-6351

Show 35 Study Locations

Sponsors and Collaborators

Sepracor, Inc.

More Information

No publications provided

Responsible Party:	Sepracor ( Sr. Medical Director )
Study ID Numbers:	190-246
Study First Received:	March 4, 2009
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00856973 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

Hypnotic
Eszopiclone
Attention Deficit/Hyperactivity Disorder
Insomnia

Children
Adolescent
Polysomnography
Actigraphy

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Disease
Nervous System Diseases
Sleep Disorders
Dyssomnias
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Sleep Disorders, Intrinsic

Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on February 09, 2010