Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-03 @ 7:47 AM
Study NCT ID:
NCT00989950
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2009-09-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Sponsor:
Cox Health Systems
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Daytsleep
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.
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.
25 patients will be enrolled in order to obtain statistical significance.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| shire IND#54,732 | OTHER | Shire Pharmaceuticals | View |