Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

Attention Deficit Hyperactivity Disorder Clinical Trial

— Zolkids  

Official title:

Efficacy, Safety and Tolerability of Zolpidem in the Treatment of Children Aged 6 to 17 Years With ADHD-Associated Insomnia. A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318448
• Other study ID #: EFC6820
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2006
• Last updated: April 6, 2009
• Start date: April 2006
• Est. completion date: August 2006

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Zolpidem (SL800750)

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency to persistent sleep (LPS) measured by polysomnography
Secondary	Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)
Secondary	Actigraphy measures of sleep characteristics
Secondary	ADHD Rating Scale-IV
Secondary	School tardiness/Attendance Reports
Secondary	Adverse events
Secondary	PE, lab