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Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD (Daytsleep)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989950
First Posted: October 6, 2009
Last Update Posted: July 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arie Ashkenasi, MD, Cox Health Systems
  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: Daytrana

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Arie Ashkenasi, MD, Cox Health Systems:

Primary Outcome Measures:
  • Sleep Latency [ Time Frame: 9 weeks ]
    Measure by daily subject sleep diary


Enrollment: 26
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daytrana 9 hr wear Drug: Daytrana
Daytrana patch 10-30 mg administered once daily for 9hr
Other Name: methylphenidate transdermal system
Experimental: Daytrana 10 hr wear Drug: Daytrana
Daytrana 10-30 mg worn once daily for 10 hr wear
Other Name: methylphenidate transdermal system
Experimental: Daytrana 11 hr wear Drug: Daytrana
Daytrana 10-30 mg worn once daily for 11 hr
Other Name: methylphenidate transdermal system
Experimental: Daytrana 12 hr wear Drug: Daytrana
Daytrana 10-30 mg worn once daily for 12 hrs

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.

25 patients will be enrolled in order to obtain statistical significance.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989950


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

Publications:
Responsible Party: Arie Ashkenasi, MD, Staff Neurologist, Cox Health Systems
ClinicalTrials.gov Identifier: NCT00989950     History of Changes
Other Study ID Numbers: cox002
shire IND#54,732 ( Other Identifier: Shire Pharmaceuticals )
First Submitted: September 30, 2009
First Posted: October 6, 2009
Results First Submitted: March 12, 2012
Results First Posted: June 14, 2012
Last Update Posted: July 19, 2012
Last Verified: July 2012

Keywords provided by Arie Ashkenasi, MD, Cox Health Systems:
daytrana
sleep latency
adhd rating scales
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents