Atomoxetine for Freezing of Gait in Parkinson's Disease

Phase 3

Completed

• Conditions: Freezing of Gait; Parkinson's Disease
• Interventions: Drug: ATM FOG in PD

• Registration Number: NCT03651856
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Results First Submitted: 2018-10-02
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-02
• Last Update Submitted: 2018-11-02
• Results First Posted: 2018-11-28
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atomoxetine	ATM FOG in PD	Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States