Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368849
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2006-08-24
Brief Title:
Atomoxetine and Huntingtons Disease
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
Atomoxetine for Attention Deficits in Adults With Mild HD A Randomized Placebo-Controlled Crossover Study
Status:
COMPLETED
Status Verified Date:
2012-12
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:
None
Brief Summary:
The purpose of this research study is to evaluate the effect of atomoxetine also known as Strattera compared to placebo inactive substance on daily activities such as attention and focus thinking ability and muscle movements in subjects with early Huntington Disease HD and attention deficit disorder ADD
Detailed Description:
No medications have been investigated to improve attention and executive functions in patients with Huntingtons disease despite the evidence that these cognitive domains can be abnormal even before motor symptom onset Because cognitive symptoms are highly associated with functional disability treatments aimed at improving cognitive functions would be of significant benefit to patients in the early stages of the disease Atomoxetine is the ideal choice for such a trial It has proven efficacy in adults with attention deficit hyperactivity disorder ADHD and it selectively targets norepinephrine and dopamine in the prefrontal cortex rather than in subcortical areas This selectivity is an advantage for patients with HD because motor side effects are less likely to be facilitated than with a psychostimulant The present study is a feasibility study in which we propose to administer either 80 milligram mg atomoxetine for 4 weeks or placebo to 20 patients with early HD who also complain of mild cognitive symptoms The groups will then crossover to the other condition atomoxetine or placebo Participants will be assessed on measures of ADHD symptoms and a sensitive battery of neuropsychological tests Based on the shared neural circuitry in ADHD and HD and the demonstrated effectiveness of atomoxetine on attention in adults with ADHD improved performance on cognitive tests of attention and executive functions and on subjects report of ADHD symptoms are expected in the atomoxetine treatment phase No changes in motor status are predicted during the study
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