Atomoxetine for Freezing of Gait in Parkinson's Disease

NCT ID: NCT03651856

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Parkinson's Disease; Freezing of Gait

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atomoxetine

Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off

Group Type: EXPERIMENTAL

ATM FOG in PD

Intervention Type: DRUG

open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Interventions

ATM FOG in PD

open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Intervention Type: DRUG

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gonzalo J Revuelta, DO

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00014009

Identifier Type: -

Identifier Source: org_study_id