Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD) - Full Text View

Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD) (Daytsleep)

This study is not yet open for participant recruitment.

Verified by Cox Health Systems, October 2009

First Received: September 30, 2009 Last Updated: October 8, 2009 History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Cox Health Systems:

Primary Outcome Measures:

The primary outcome is that longer patch wear times will lead to decreased sleep latency. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

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.

Detailed Description:

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

Criteria

Inclusion Criteria:

ADHD without significant comorbidity

Exclusion Criteria:

Cardiac disorder
Hypertension
Thyroid disease
Glaucoma
History of sudden death, motor tics and/or Tourette's syndrome
Hypersensitivity to methylphenidate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989950

Contacts

Contact: Arie Ashkenasi, MD

417-269-1010

arie.ashkenasi@coxhealth.com

Locations

United States, Missouri
Pediatric Neurology of the Ozarks
springfield, Missouri, United States, 65807

Sponsors and Collaborators

Cox Health Systems

Investigators

Principal Investigator:

arie ashkenasi

pediatric neurology of the ozarks

More Information

No publications provided

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

Keywords provided by Cox Health Systems:

daytrana
sleep latency
adhd rating scales
ADHD

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 04, 2010