Freezing of Gait, Parkinson's Disease
Conditions
Brief summary
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.
Interventions
DRUGATM FOG in PD
open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4 2. A positive response to item 14 of the UPDRS, part 2. 3. Age range 18-80 4. Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue 5. Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit. 6. Stable on PD medications for ≥ 3 months \-
Exclusion criteria
1. Intolerance to drug class 2. Mini-Mental Status Examination \<26/30 3. No observable episodes of freezing of gait despite common visual cues 4. Not on stable PD medications for 3 months 5. Subjects who whose gait disturbance is due to other conditions not related to PD or FOG. 6. Current use of monoamine oxidase inhibitor (MAO-I) 7. Hypersensitivity to drug class 8. Narrow angle glaucoma 9. Pheochromocytoma 10. 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). 11. Patients with uncontrolled hypertension. 12. Patients with a history of symptomatic tachyarrhythmias. 13. Presence of uncontrolled depression and suicidal ideation. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | week 8 | Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Atomoxetine |
|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 3.5 |
| Region of Enrollment United States | 10 Count of Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events
Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
Time frame: week 8
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atomoxetine | Number of Participants With Treatment Emergent Adverse Events | Increase in Creatine | 3 Participants |
| Atomoxetine | Number of Participants With Treatment Emergent Adverse Events | Nausea | 1 Participants |
| Atomoxetine | Number of Participants With Treatment Emergent Adverse Events | Mild Jitters | 1 Participants |
| Atomoxetine | Number of Participants With Treatment Emergent Adverse Events | Worsening Fog (Freezing of Gait) | 1 Participants |
| Atomoxetine | Number of Participants With Treatment Emergent Adverse Events | Diarrhea | 1 Participants |
| Atomoxetine | Number of Participants With Treatment Emergent Adverse Events | Worsening Dyskinesia | 1 Participants |