Atomoxetine for Freezing of Gait in Parkinson's Disease

Parkinson's Disease Clinical Trial

— ATMFOG  

Official title:

A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651856
• Other study ID #: Pro00014009
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ATM FOG in PD
open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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