- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318448
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia (Zolkids)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Laval, Canada
- Sanofi-Aventis Administrative Office
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Latency to persistent sleep (LPS) measured by polysomnography
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
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Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)
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Actigraphy measures of sleep characteristics
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ADHD Rating Scale-IV
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School tardiness/Attendance Reports
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PE, lab
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Sleep Initiation and Maintenance Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Agents
- Sleep Aids, Pharmaceutical
- GABA-A Receptor Agonists
- GABA Agonists
- Zolpidem
Other Study ID Numbers
- EFC6820
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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