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

July 16, 2012 updated by: Arie Ashkenasi, MD, Cox Health Systems

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Pediatric Neurology of the Ozarks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daytrana 9 hr wear
Drug: Daytrana
Daytrana patch 10-30 mg administered once daily for 9hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 10 hr wear
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 11 hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 12 hrs
Experimental: Daytrana 10 hr wear
Drug: Daytrana
Daytrana patch 10-30 mg administered once daily for 9hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 10 hr wear
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 11 hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 12 hrs
Experimental: Daytrana 11 hr wear
Drug: Daytrana
Daytrana patch 10-30 mg administered once daily for 9hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 10 hr wear
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 11 hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 12 hrs
Experimental: Daytrana 12 hr wear
Drug: Daytrana
Daytrana patch 10-30 mg administered once daily for 9hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 10 hr wear
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 11 hr
Other Names:
  • methylphenidate transdermal system
Drug: Daytrana
Daytrana 10-30 mg worn once daily for 12 hrs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Latency
Time Frame: 9 weeks
Measure by daily subject sleep diary
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cox Health Systems

Investigators

  • Principal Investigator: arie ashkenasi, Pediatric Neurology of the Ozarks

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cox002
  • shire IND#54,732 (Other Identifier: Shire Pharmaceuticals)

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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