Trial record 9 of 111 for:    Chorea

Atomoxetine and Huntington's Disease

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Beglinger, Leigh J, University of Iowa
ClinicalTrials.gov Identifier:
NCT00368849
First received: August 24, 2006
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Huntington Disease
Chorea
Drug: atomoxetine
Drug: Matching Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Conners' Adult Attention Rating Scale (CAARS) [ Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment ] [ Designated as safety issue: No ]
    The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm.

  • Attention Composite Score [ Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment ] [ Designated as safety issue: No ]
    The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm.

  • Executive Composite Score [ Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment ] [ Designated as safety issue: No ]
    The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm.


Secondary Outcome Measures:
  • Symptom Checklist-90-Revised (SCL-90-R) [ Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment ] [ Designated as safety issue: No ]
    Psychiatric symptoms were evaluated with the Symptom Checklist-90-Revised, a self report measure of psychiatric symptoms. The measure produces raw scores and normed scores (T scores Mean = 50), with higher values representing greater impairment. The outcome reported was change in score from baseline for each treatment arm.

  • Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score [ Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment ] [ Designated as safety issue: No ]
    Although changes in motor symptoms were not hypothesized, the Unified Huntington Disease Rating Scale motor examination was administered at every visit. An experienced motor rater completes a motor examination and rates the participant on several motor tasks. Total score ranges from 0 - 124, with higher scores indicating a worse outcome. The outcome reported was change in score from baseline for each treatment arm.


Enrollment: 20
Study Start Date: November 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 milligram twice a day atomoxetine
Participants received 40 milligram twice a day atomoxetine for 4 weeks.
Drug: atomoxetine
This study utilizes a crossover design. Accordingly, half of the participants receive 40 milligram twice a day atomoxetine at arm one while the remaining half receive this intervention at arm two.
Other Name: Strattera
Placebo Comparator: Twice a day matching placebo
Participants received twice a day matching placebo for 4 weeks.
Drug: Matching Placebo
This study utilizes a crossover design. Accordingly, half of the participants receive twice a day matching placebo at arm one while the remaining half receive this intervention at arm two.
Other Name: Sugar pill

Detailed Description:

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed Huntington's disease (HD) diagnosis
  • Age 18 to 65
  • Must have mild HD
  • Must have complaints of poor attention

Exclusion Criteria:

  • Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms
  • Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe anxiety
  • Current use of a monoamine oxidase inhibitor (MAOI) medication
  • Pregnancy
  • Uncontrolled hypertension
  • Tachycardia
  • Cardiovascular or cerebrovascular disease
  • History of a loss of consciousness for greater than (or equal to) 5 minutes
  • Having any neurological disorder or insult other than Huntington disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368849

Locations
United States, Iowa
The University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Eli Lilly and Company
Investigators
Principal Investigator: Leigh J Beglinger, Ph.D. The University of Iowa
  More Information

Publications:
Campodonico, J. et al. When does Huntington's Disease begin? J Intnl Neuropsychol Soc, 4: 1998, 467-473.
Beglinger, L. et al. The association between speed of processing and cerebral white matter volume in patients with mild Huntington's disease [abstract]. Poster session accepted at the Annual Meeting of the Cognitive Neuroscience Society, April, 2004
Conners, CK et al. Conners' Adult ADHD Rating Scales (CAARS). 1999. North Tonawanda, NY: Multi-Health Systems.

Responsible Party: Beglinger, Leigh J, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00368849     History of Changes
Other Study ID Numbers: 200508775
Study First Received: August 24, 2006
Results First Received: May 9, 2011
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Huntington Disease
Chorea
Attention
ADHD
ADD
Strattera
Atomoxetine

Additional relevant MeSH terms:
Chorea
Huntington Disease
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Dementia
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014