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Atomoxetine for Freezing of Gait in Parkinson's Disease

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

NCT03651856•Medical University of South Carolina

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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).
+4 more criteria

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

November 28, 2018

Enrollment

ACTUAL participants

Conditions

Parkinson's DiseaseFreezing of Gait

Interventions

ATM FOG in PD

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Atomoxetine for Freezing of Gait in Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations