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Subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has been found to be well tolerated in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Experimental | Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATM FOG in PD | Drug | open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait) | week 8 |
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Inclusion Criteria:
Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
A positive response to item 14 of the UPDRS, part 2.
Age range 18-80
Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
Stable on PD medications for ≥ 3 months
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Exclusion Criteria:
Intolerance to drug class
Mini-Mental Status Examination <26/30
No observable episodes of freezing of gait despite common visual cues
Not on stable PD medications for 3 months
Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
Current use of monoamine oxidase inhibitor (MAO-I)
Hypersensitivity to drug class
Narrow angle glaucoma
Pheochromocytoma
Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats per minute in heart rate).
Patients with uncontrolled hypertension.
Patients with a history of symptomatic tachyarrhythmias.
Presence of uncontrolled depression and suicidal ideation.
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo J Revuelta, DO | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events | Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait) | Posted | Count of Participants | Participants | week 8 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in Creatine | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gonzalo Revuelta | Medical University of SC | 843-792-7262 | revuelta@musc.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Count of Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 8 |
| 10 |
| Worsening Fog (Freezing of Gait) | Nervous system disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Worsening Dyskinesia | Nervous system disorders | Systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Mild Jitters | Nervous system disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |