A Phase 2 interventional study of atomoxetine and Matching Placebo in Huntington Disease and Chorea, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-12-20.
Sponsored by University of Iowa · Phase 2, Interventional, and Treatment
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).
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.
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 207 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.
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Participants received 40 milligram twice a day atomoxetine for 4 weeks.
Drug: atomoxetine
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 40 milligram twice a day atomoxetine at arm one while the remaining half receive this intervention at arm two.
Also known as: Strattera
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.
Also known as: Sugar pill
Conners' Adult Attention Rating Scale (CAARS)
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.
Time frame: There are two time points for this measure: baseline and after 4 weeks of treatment
Attention Composite Score
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.
Time frame: There are two time points for this measure: baseline and after 4 weeks of treatment
Executive Composite Score
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.
Time frame: There are two time points for this measure: baseline and after 4 weeks of treatment
Symptom Checklist-90-Revised (SCL-90-R)
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.
Time frame: There are two time points for this measure: baseline and after 4 weeks of treatment
Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score
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.
Time frame: There are two time points for this measure: baseline and after 4 weeks of treatment
Participants (number = 20) were recruited using advertisements and through the University of Iowa Huntington Disease (HD) Registry at a rate of 1.40 individuals per month from September 2006 through November 2007 (i.e., 14.3 months).
| Milestone | Atomoxetine (4 Weeks) Then Placebo (4 Weeks) | Placebo (4 Weeks) Then Atomoxetine (4 Weeks) |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 8 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
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.
| units on a scale | Atomoxetine | Placebo |
|---|---|---|
| Conners' Adult Attention Rating Scale (CAARS) | -2.88 ± 1.1 | -2.24 ± 1.1 |
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.
| Units on a scale | Atomoxetine | Placebo |
|---|---|---|
| Attention Composite Score | -0.13 ± 0.07 | 0.02 ± 0.06 |
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.
| units on a scale | Atomoxetine | Placebo |
|---|---|---|
| Executive Composite Score | -1.68 ± 1.4 | -2.94 ± 1.4 |
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.
| units on a scale | Atomoxetine | Placebo |
|---|---|---|
| Symptom Checklist-90-Revised (SCL-90-R) | -4.20 ± 1.9 | -4.64 ± 1.8 |
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.
| units on a scale | Atomoxetine | Placebo |
|---|---|---|
| Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score | 0.42 ± 1.8 | -0.35 ± 1.7 |
Collected over Adverse events were reported from September 2006 through November 2007 (14.3 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atomoxetine | — | 0/20 (0%) | 10/18 (55.6%) |
| Matching Placebo | — | 3/20 (15%) | 7/20 (35%) |
| Event | Atomoxetine | Matching Placebo |
|---|---|---|
| Inpatient HospitalizationPsychiatric disorders | 0/20 | 1/20 |
| An Important Medical EventRenal and urinary disorders | 0/20 | 1/20 |
| An Important Medical EventPsychiatric disorders | 0/20 | 1/20 |
| Event | Atomoxetine | Matching Placebo |
|---|---|---|
| XerostomiaGastrointestinal disorders | 7/18 | 2/20 |
| Appetite LossMetabolism and nutrition disorders | 4/18 | 0/20 |
| InsomniaNervous system disorders | 4/18 | 1/20 |
| DizzinessNervous system disorders | 3/18 | 2/20 |
| Weight LossMetabolism and nutrition disorders | 2/18 | 2/20 |
| ConstipationGastrointestinal disorders | 2/18 | 0/20 |
| NauseaGastrointestinal disorders | 2/18 | 0/20 |
| HeadacheNervous system disorders | 2/18 | 1/20 |
| Difficulty UrinatingRenal and urinary disorders | 2/18 | — |
| Urine RetentionRenal and urinary disorders | 2/18 | 0/20 |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Age Continuous(years) | All Participants |
|---|---|
| Mean | 46.20 ± 10.288 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 14 |
| Male | 6 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 20 |
The record gives a start of Nov 2005, a primary completion of Feb 2008 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2012, 4 years 9 months after primary completion.
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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atomoxetine