Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00989950
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : June 14, 2012
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Arie Ashkenasi, MD, Cox Health Systems

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder INSOMNIA Drug: Daytrana Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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)
Study Start Date : December 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, Missouri
Pediatric Neurology of the Ozarks
Springfield, Missouri, United States, 65807
Sponsors and Collaborators
Cox Health Systems
Investigators
Layout table for investigator information
Principal Investigator: arie ashkenasi pediatric neurology of the ozarks
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Arie Ashkenasi, MD, Staff Neurologist, Cox Health Systems
ClinicalTrials.gov Identifier: NCT00989950    
Other Study ID Numbers: cox002
shire IND#54,732 ( Other Identifier: Shire Pharmaceuticals )
First Posted: October 6, 2009    Key Record Dates
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:
Layout table for MeSH terms
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Nervous System Diseases
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
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