Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418262
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-01-02
Brief Title:
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADDADHD
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
An Open-label Study of the Long Term Tolerability and Safety of Atomoxetine in Treating the Inattention Impulsivity and Hyperactivity in Children With Fetal-Alcohol Syndrome or Effects
Status:
COMPLETED
Status Verified Date:
2017-06
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:
B4Z-US-050
Brief Summary:
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome
Detailed Description:
Abnormalities of attention function and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure Previous psychological studies have examined either core attention deficit hyperactivity ADHD symptoms of hyperactivity inattention and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome FAS and ADHD Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD This study will determine if atomoxetine HCL significantly reduces symptoms of ADDADHD in children with fetal alcohol exposure
Study Oversight
Has Oversight DMC:
None
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?:
None