Atomoxetine for Freezing of Gait in Parkinson's Disease

Last updated: November 2, 2018
Sponsor: Medical University of South Carolina
Overall Status: Completed

Phase

3

Condition

Dyskinesias

Parkinson's Disease

Treatment

N/A

Clinical Study ID

NCT03651856
Pro00014009
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehnand 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 observedfreezing episode which may be triggered by visual cue

  5. Letter of medical clearance by primary care physician dated within preceding 2 monthsof subject's initial active study visit.

  6. Stable on PD medications for ≥ 3 months

Exclusion

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 orFOG.

  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 wouldbe expected to deteriorate if their heart rate or blood pressure were to increase in aclinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beatsper 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.

Study Design

Total Participants: 10
Study Start date:
January 01, 2013
Estimated Completion Date:
February 28, 2014

Connect with a study center

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

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