Efficacy, Safety, and Tolerability of Ambien (Zolpidem) i... | NCT00318448

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Mar 14, 2006

First Submission Date that Met QC Criteria

Apr 25, 2006

First Posted Date

Apr 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2009

Last Update Posted Date

Apr 7, 2009Estimated

Description Module

Brief Summary

There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD associated insomnia.

Detailed Description

The study is being conducted in the United States. It consists of 3 segments:

Segment A: 2 to 21 day screening period
Segment B: 8-week double-blind treatment period
Segment C: 1-week follow-up period

Subjects will have a polysomnography in a sleep lab two times during the study (at baseline and between visit 4-5) and also be required to wear an actigraphy monitoring tool. There will be several questionnaires completed throughout the study: CGI-child, CGI-parent/legal guardian, ADHD Rating Scale-IV, and the Pediatric Daytime Sleepiness Scale.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Name	Type	Description	Arm Group Labels	Other Names
Zolpidem (SL800750)	Drug

Measure	Description	Time Frame
Latency to persistent sleep (LPS) measured by polysomnography

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between the ages of 6 and 17 years, inclusive
Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria)
Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep
The sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication.
Subjects should be stabilized on all long-term therapy, including treatment of ADHD, for at least one month prior to study entry.
Subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study.

Exclusion Criteria:

Mental retardation
Autistic spectrum disorder
A history of sleep apnea
A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and DSM-IV-TR criteria
Current history of substance abuse/dependence
Known hypersensitivity to zolpidem or previous adverse experience with zolpidem
Pregnant or breast-feeding
Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19403468	Derived	Blumer JL, Findling RL, Shih WJ, Soubrane C, Reed MD. Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age. Pediatrics. 2009 May;123(5):e770-6. doi: 10.1542/peds.2008-2945.

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D007319	Sleep Initiation and Maintenance Disorders

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Measure	Description	Time Frame
Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)
Actigraphy measures of sleep characteristics