An interventional study of Atomoxetine in Parkinson's Disease, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance levels of brain chemicals that may be affected in people with executive dysfunction, (difficulties with organization, task completion, and priority setting). Thus, atomoxetine has the potential to improve executive dysfunction in people with Parkinson's disease (PD).
The goal of this study is to provide preliminary data on the effectiveness and tolerability of atomoxetine for the treatment of executive dysfunction in patients with PD.
Parkinson's disease (PD), while defined by its motor abnormalities and associated dopaminergic loss, is invariably accompanied by cognitive impairment. Early in the disease course, the deficits are characterized by executive dysfunction with difficulties on tasks that involve information processing, attention, sorting, planning, set-shifting, and working memory and are subserved by neural connections with prefrontal brain regions. There has been little effort to identify treatments for these PD-related cognitive impairments, despite their disabling and distressing effects. Accordingly, the goal of this proposal is to conduct a small pilot study to determine the effectiveness and tolerability of atomoxetine, a selective norepinephrine reuptake inhibitor, for the treatment of executive dysfunction in patients with PD.
Atomoxetine (Strattera) is currently approved by the FDA for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine enhances dopaminergic and noradrenergic transmission in frontal regions that are also implicated in executive dysfunction and thus has the potential to improve executive dysfunction in PD as well as other neurological conditions. Results of the study will be used to develop a larger placebo-controlled trial of atomoxetine, if appropriate, as well as inform the design of other clinical trials on potential treatments for cognitive dysfunction in PD.
The overall hypothesis is that atomoxetine will be an effective and safe treatment for executive dysfunction in PD.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
Open-Label Uncontrolled Active Drug Intervention, No comparator
Drug: Atomoxetine
Open Label uncontrolled active Drug intervention
Also known as: Strattera (Brand Name)
Clinical Global Impression of Change-Clinician Rated Score (CGIC-C)
CGIC-C score is a clinician's rating of change (improvement or worsening) over the course of the trial in an individual's symptoms and their global impact on function and clinical status, i.e., the global impact of the intervention that the patient is better, unchanged, or worse). Scale ranges1 to 7 which equates to from very much worse to very much improved. The CGIC-C score is not an appropriate baseline measure since it represents change after initiating an intervention. In addition, a baseline Clinical Global Impression of Severity-Clinician Rated Score (CGIS-C) is not appropriate to compare to CGIC-C, as a patient with severe disease might show clinically meaningful improvement (i.e., very much improved) from an intervention while still being severely affected on the CGIS-C score; by contrast, a patient with mild CGIS-C could have minimal or no change on the CGIC-C score. This study was not designed to assess the influence of disease severity on the primary outcome (CGIC-C).
Time frame: 8 weeks
Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale
The CAARS-L Inattention/Memory subscale, a primary self-rated outcome measure in this study, measures the frequency of behaviors associated with executive dysfunction, such as task incompletion, disorganization, distractibility, and difficulty planning, multi-tasking, and initiating tasks. CAARS-L scores are depicted as group Mean (SD) T scores, derived from comparison to CAARS norms based on gender and age in a normative sample. Similar to the FrSBE, higher T-scores are associated with greater symptom severity and T-scores above 65 represent symptoms of clinical significance.
Time frame: baseline and 8 weeks
Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore
Frontal Systems Behavioral Scale (FrSBe) Executive Function subscore is on of the 3 subscales of the FrSBE, a scale designed to identify and quantify behavioral problems associated with frontal lobe dysfunction. The other subscales are Apathy and Disinhibition. Each item is rated on a 5-point Likert scale. Totals are generated for each subscale and normative data is referenced (based on patient gender, age and education) and standardized T-scores are determined). For all FrSBe scales, T scores ≥ 65 are considered clinically significant and scores of 60 to 64 represent likely borderline impairment.
Time frame: 8 weeks
Parkinson's disease (PD) outpatients (recruited 2005-2008 via Johns Hopkins clinics and community) had clinically significant Executive Dysfunction, defined as moderately severe problems with disorganization, distractibility, task completion, planning or problem solving that impaired function, were a decline from pre-PD, and verified by informant.
| Milestone | Atomoxetine Open Label |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
CGIC-C score is a clinician's rating of change (improvement or worsening) over the course of the trial in an individual's symptoms and their global impact on function and clinical status, i.e., the global impact of the intervention that the patient is better, unchanged, or worse). Scale ranges1 to 7 which equates to from very much worse to very much improved. The CGIC-C score is not an appropriate baseline measure since it represents change after initiating an intervention. In addition, a baseline Clinical Global Impression of Severity-Clinician Rated Score (CGIS-C) is not appropriate to compare to CGIC-C, as a patient with severe disease might show clinically meaningful improvement (i.e., very much improved) from an intervention while still being severely affected on the CGIS-C score; by contrast, a patient with mild CGIS-C could have minimal or no change on the CGIC-C score. This study was not designed to assess the influence of disease severity on the primary outcome (CGIC-C).
| Participants | Atomoxetine Open Label |
|---|---|
| Very Much Improved | 3 |
| Much Improved | 6 |
| Minimally Improved | 1 |
| No Change | 2 |
| Minimally Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
The CAARS-L Inattention/Memory subscale, a primary self-rated outcome measure in this study, measures the frequency of behaviors associated with executive dysfunction, such as task incompletion, disorganization, distractibility, and difficulty planning, multi-tasking, and initiating tasks. CAARS-L scores are depicted as group Mean (SD) T scores, derived from comparison to CAARS norms based on gender and age in a normative sample. Similar to the FrSBE, higher T-scores are associated with greater symptom severity and T-scores above 65 represent symptoms of clinical significance.
| units on a scale | Atomoxetine (Strattera) |
|---|---|
| Baseline Visit | 60 ± 10 |
| Final Visit (8 weeks) | 52 ± 10 |
Frontal Systems Behavioral Scale (FrSBe) Executive Function subscore is on of the 3 subscales of the FrSBE, a scale designed to identify and quantify behavioral problems associated with frontal lobe dysfunction. The other subscales are Apathy and Disinhibition. Each item is rated on a 5-point Likert scale. Totals are generated for each subscale and normative data is referenced (based on patient gender, age and education) and standardized T-scores are determined). For all FrSBe scales, T scores ≥ 65 are considered clinically significant and scores of 60 to 64 represent likely borderline impairment.
| T-score | Atomoxetine |
|---|---|
| Baseline Visit | 67 ± 11 |
| Final Visit | 58 ± 15 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atomoxetine | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Event | Atomoxetine |
|---|---|
| Reduced SleepNervous system disorders | 6/12 |
| ConstipationGastrointestinal disorders | 5/12 |
| Nausea/vomitingGastrointestinal disorders | 3/12 |
| ConfusionNervous system disorders | 3/12 |
| Slowed movementsNervous system disorders | 3/12 |
| DiaphoresisSkin and subcutaneous tissue disorders | 3/12 |
| FatigueGeneral disorders | 2/12 |
| DepressionPsychiatric disorders | 2/12 |
| AgitationPsychiatric disorders | 2/12 |
| increased dream activityNervous system disorders | 2/12 |
All enrolled subjects
| Age, Categorical(Participants) | Atomoxetine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Age, Continuous(years) | Atomoxetine |
|---|---|
| Mean | 57.3 ± 7.2 |
| Sex: Female, Male(Participants) | Atomoxetine |
|---|---|
| Female | 7 |
| Male | 5 |
| Region of Enrollment(Participants) | Atomoxetine |
|---|---|
| United States | 12 |
Plan to share: No
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