Atomoxetine and Huntington's Disease
NCT00368849, Phase 2, Completed, University of Iowa; results first posted 2012-11-27
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Atomoxetine and Huntington's Disease | ClinicalTrials.gov |
| NCT number | NCT00368849 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 20 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Iowa | ClinicalTrials.gov |
| Conditions | Huntington Disease, Chorea | ClinicalTrials.gov |
| Interventions | atomoxetine, Matching Placebo | ClinicalTrials.gov |
| First posted | 2006-08-29 | ClinicalTrials.gov |
| Last updated | 2012-12-20 | ClinicalTrials.gov |
| Results first posted | 2012-11-27 | ClinicalTrials.gov |
| Limitations and caveats | We cannot rule out carryover effects. Additionally, the sample size may be too low to detect small treatment changes, the treatment duration may have been too brief, and our participants had only early-stage HD which may have limited the drug effect. | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Conners' Adult Attention Rating Scale (CAARS) | There are two time points for this measure: baseline and after 4 weeks of treatment | 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. | ClinicalTrials.gov |
| Primary | Attention Composite Score | There are two time points for this measure: baseline and after 4 weeks of treatment | 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. | ClinicalTrials.gov |
| Primary | Executive Composite Score | There are two time points for this measure: baseline and after 4 weeks of treatment | 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. | ClinicalTrials.gov |
| Secondary | Symptom Checklist-90-Revised (SCL-90-R) | There are two time points for this measure: baseline and after 4 weeks of treatment | 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. | ClinicalTrials.gov |
| Secondary | Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score | There are two time points for this measure: baseline and after 4 weeks of treatment | 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. | ClinicalTrials.gov |
Outcomes 5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Conners' Adult Attention Rating Scale (CAARS) | There are two time points for this measure: baseline and after 4 weeks of treatment | Analysis was based on number of completers | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Attention Composite Score | There are two time points for this measure: baseline and after 4 weeks of treatment | Analysis was based on number of completers. | Units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Executive Composite Score | There are two time points for this measure: baseline and after 4 weeks of treatment | Analysis was based on number of completers. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Symptom Checklist-90-Revised (SCL-90-R) | There are two time points for this measure: baseline and after 4 weeks of treatment | Analysis was based on number of completers. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score | There are two time points for this measure: baseline and after 4 weeks of treatment | Analysis was based on number of completers. | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Conners' Adult Attention Rating Scale (CAARS) | Atomoxetine | -2.88 | Standard Error 1.1 | units on a scale | ClinicalTrials.gov | |
| Conners' Adult Attention Rating Scale (CAARS) | Placebo | -2.24 | Standard Error 1.1 | units on a scale | ClinicalTrials.gov | |
| Attention Composite Score | Atomoxetine | -0.13 | Standard Error 0.07 | Units on a scale | ClinicalTrials.gov | |
| Attention Composite Score | Placebo | 0.02 | Standard Error 0.06 | Units on a scale | ClinicalTrials.gov | |
| Executive Composite Score | Atomoxetine | -1.68 | Standard Error 1.4 | units on a scale | ClinicalTrials.gov | |
| Executive Composite Score | Placebo | -2.94 | Standard Error 1.4 | units on a scale | ClinicalTrials.gov | |
| Symptom Checklist-90-Revised (SCL-90-R) | Atomoxetine | -4.20 | Standard Error 1.9 | units on a scale | ClinicalTrials.gov | |
| Symptom Checklist-90-Revised (SCL-90-R) | Placebo | -4.64 | Standard Error 1.8 | units on a scale | ClinicalTrials.gov | |
| Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score | Atomoxetine | 0.42 | Standard Error 1.8 | units on a scale | ClinicalTrials.gov | |
| Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score | Placebo | -0.35 | Standard Error 1.7 | units on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine (4 Weeks) Then Placebo (4 Weeks) | 10 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo (4 Weeks) Then Atomoxetine (4 Weeks) | 10 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Atomoxetine (4 Weeks) Then Placebo (4 Weeks) | 10 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo (4 Weeks) Then Atomoxetine (4 Weeks) | 8 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Atomoxetine (4 Weeks) Then Placebo (4 Weeks) | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo (4 Weeks) Then Atomoxetine (4 Weeks) | 2 | ClinicalTrials.gov |
Adverse events 30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Weight Loss | Metabolism and nutrition disorders | Atomoxetine | 2 | 18 | 2 | ClinicalTrials.gov |
| other | Weight Loss | Metabolism and nutrition disorders | Matching Placebo | 2 | 20 | 2 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | Atomoxetine | 2 | 18 | 2 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | Matching Placebo | 0 | 20 | 0 | ClinicalTrials.gov |
| other | Appetite Loss | Metabolism and nutrition disorders | Atomoxetine | 4 | 18 | 4 | ClinicalTrials.gov |
| other | Appetite Loss | Metabolism and nutrition disorders | Matching Placebo | 0 | 20 | 0 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 2 | 18 | 2 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Matching Placebo | 0 | 20 | 0 | ClinicalTrials.gov |
| other | Xerostomia | Gastrointestinal disorders | Atomoxetine | 7 | 18 | 7 | ClinicalTrials.gov |
| other | Xerostomia | Gastrointestinal disorders | Matching Placebo | 2 | 20 | 2 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Atomoxetine | 3 | 18 | 3 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Matching Placebo | 2 | 20 | 2 | ClinicalTrials.gov |
| other | Insomnia | Nervous system disorders | Atomoxetine | 4 | 18 | 4 | ClinicalTrials.gov |
| other | Insomnia | Nervous system disorders | Matching Placebo | 1 | 20 | 1 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Atomoxetine | 2 | 18 | 2 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Matching Placebo | 1 | 20 | 1 | ClinicalTrials.gov |
| other | Difficulty Urinating | Renal and urinary disorders | Atomoxetine | 2 | 18 | 2 | ClinicalTrials.gov |
| other | Difficulty Urinating | Renal and urinary disorders | Matching Placebo | 0 | 0 | 0 | ClinicalTrials.gov |
| other | Urine Retention | Renal and urinary disorders | Atomoxetine | 2 | 18 | 2 | ClinicalTrials.gov |
| other | Urine Retention | Renal and urinary disorders | Matching Placebo | 0 | 20 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ClinicalTrials.gov | ||
| Total, all-cause mortality | Matching Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Atomoxetine | 10 | 18 | ClinicalTrials.gov |
| Total, other adverse events | Matching Placebo | 7 | 20 | ClinicalTrials.gov |
| Total, serious adverse events | Atomoxetine | 0 | 20 | ClinicalTrials.gov |
| Total, serious adverse events | Matching Placebo | 3 | 20 | ClinicalTrials.gov |
Papers 13
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 2002218 | BACKGROUND | PubMed |
| 8458085 | BACKGROUND | PubMed |
| 9055518 | BACKGROUND | PubMed |
| 9443488 | BACKGROUND | PubMed |
| 9585725 | BACKGROUND | PubMed |
| 9679784 | BACKGROUND | PubMed |
| 9745236 | BACKGROUND | PubMed |
| 9878201 | BACKGROUND | PubMed |
| 10668713 | BACKGROUND | PubMed |
| 10982499 | BACKGROUND | PubMed |
| 11198293 | BACKGROUND | PubMed |
| 11524475 | BACKGROUND | PubMed |
| 12547466 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Atomoxetine vs Matching Placebo: serious adverse events | Trial comparisons |
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 2-Back Task | Primary outcome | ConductCognition |
| Choice Reaction Time | Primary outcome | ConductCognition |
| Letter-Number Sequencing Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)