Back to resultsAtomoxetine for Freezing of Gait in Parkinson's Disease (ATMFOG)
Primary Purpose
Parkinson's Disease, Freezing of Gait
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ATM FOG in PD
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
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
-
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.
-
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atomoxetine
Arm Description
Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events
Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
Secondary Outcome Measures
Full Information
NCT ID
NCT03651856
First Posted
July 2, 2018
Last Updated
November 2, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03651856
Brief Title
Atomoxetine for Freezing of Gait in Parkinson's Disease
Acronym
ATMFOG
Official Title
A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Freezing of Gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off
Intervention Type
Drug
Intervention Name(s)
ATM FOG in PD
Intervention Description
open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events
Description
Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
Time Frame
week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo J Revuelta, DO
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Atomoxetine for Freezing of Gait in Parkinson's Disease
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