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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:
Information provided by (Responsible Party):
Arie Ashkenasi, MD, Cox Health Systems
ClinicalTrials.gov Identifier:
NCT00989950
First received: September 30, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by Cox Health Systems:

Primary Outcome Measures:
  • Sleep Latency [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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 Names:
  • Daytrana
  • methylphenidate transdermal system
Experimental: Daytrana 10 hr wear Drug: Daytrana
Daytrana 10-30 mg worn once daily for 10 hr wear
Other Names:
  • Daytrana
  • methylphenidate transdermal system
Experimental: Daytrana 11 hr wear Drug: Daytrana
Daytrana 10-30 mg worn once daily for 11 hr
Other Names:
  • Daytrana
  • 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

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

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
Study First Received: September 30, 2009
Results First Received: March 12, 2012
Last Updated: July 16, 2012
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:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013