Atomoxetine for Freezing of Gait in Parkinson's Disease
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 11/30/2018 |
Start Date: | January 2013 |
End Date: | February 2014 |
A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
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.
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.
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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Click here to add this to my saved trials