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Sponsors and Collaborators: |
University of Iowa Eli Lilly and Company |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00368849 |
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 HD and attention deficit disorder.
Condition | Intervention | Phase |
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Huntington Disease Chorea |
Drug: atomoxetine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study |
Enrollment: | 20 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Placebo or 40mg bid atomoxetine, using a 1:1 allocation
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Drug: atomoxetine
This study utilizes a crossover design. Participants receive 40mg bid atomoxetine or placebo at arm 01 and arm 02 using a 1:1 allocation
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2: Experimental
40mg bid atomoxetine or placebo, using a 1:1 allocation
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Drug: atomoxetine
This study utilizes a crossover design. Participants receive 40mg bid atomoxetine or placebo at arm 01 and arm 02 using a 1:1 allocation
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No medications have been investigated to improve attention and executive functions in patients with Huntington's 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 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 mg atomoxetine for 4 weeks or placebo to 20 patients with early HD and 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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Iowa | |
The University of Iowa | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Leigh J Beglinger, Ph.D. | The University of Iowa |
Responsible Party: | University of Iowa ( Leigh Beglinger, Ph.D. ) |
Study ID Numbers: | 200508775 |
Study First Received: | August 24, 2006 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00368849 History of Changes |
Health Authority: | United States: Institutional Review Board |
Huntington Disease Chorea Attention ADHD |
ADD Strattera Atomoxetine |
Neurotransmitter Agents Ganglion Cysts Adrenergic Agents Basal Ganglia Diseases Atomoxetine Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Cognition Disorders Chorea |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Neurologic Manifestations Dementia Huntington Disease Delirium |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Basal Ganglia Diseases Physiological Effects of Drugs Atomoxetine Neurodegenerative Diseases Brain Diseases Signs and Symptoms Heredodegenerative Disorders, Nervous System Movement Disorders |
Mental Disorders Dementia Nervous System Diseases Central Nervous System Diseases Dyskinesias Cognition Disorders Pharmacologic Actions Chorea Delirium, Dementia, Amnestic, Cognitive Disorders Genetic Diseases, Inborn Neurologic Manifestations Huntington Disease |