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| Sponsor: | Cox Health Systems |
|---|---|
| Information provided by: | Cox Health Systems |
| ClinicalTrials.gov Identifier: | NCT00989950 |
Purpose
Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.
| Condition | Intervention |
|---|---|
|
Attention Deficit Hyperactivity Disorder Insomnia |
Drug: methylphenidate transdermal system |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With ADHD |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Daytrana: Experimental |
Drug: methylphenidate transdermal system
Daytrana patch 10mg, 15mg, 20mg, 30mg administered once daily for 9hr, 10hr, 11hr and 12 hr wear.
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Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.
50 patients will be enrolled in order to obtain statistical significance.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Arie Ashkenasi, MD | 417-269-1010 | arie.ashkenasi@coxhealth.com |
| United States, Missouri | |
| Pediatric Neurology of the Ozarks | |
| springfield, Missouri, United States, 65807 | |
| Principal Investigator: | arie ashkenasi | pediatric neurology of the ozarks |
More Information
| Responsible Party: | pediatric neurology of the ozarks ( arie ashkenasi MD. ) |
| Study ID Numbers: | cox002, shire IND#54,732 |
| Study First Received: | September 30, 2009 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00989950 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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daytrana sleep latency adhd rating scales ADHD |
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Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants Dyskinesias |
Pharmacologic Actions Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Central Nervous System Agents |