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

INSOMNIA Clinical Trial

— Daytsleep  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989950
• Other study ID #: cox002
• Secondary ID: shire IND#54,732
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: July 16, 2012
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: July 2012
• Source: Cox Health Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis
• INSOMNIA

Intervention

Drug:
• Daytrana
Daytrana patch 10-30 mg administered once daily for 9hr
• Daytrana
Daytrana 10-30 mg worn once daily for 10 hr wear
• Daytrana
Daytrana 10-30 mg worn once daily for 11 hr
• Daytrana
Daytrana 10-30 mg worn once daily for 12 hrs

Locations

Country	Name	City	State
United States	Pediatric Neurology of the Ozarks	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Cox Health Systems

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ashkenasi A. Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder. Pediatr Neurol. 2011 Dec;45(6):381-6. doi: 10.1016/j.pediatrneurol.2011.09.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Latency	Measure by daily subject sleep diary	9 weeks	No