Atomoxetine for Freezing of Gait in Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Freezing of Gait Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
A positive response to item 14 of the UPDRS, part 2.
Age range 18-80
Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
Stable on PD medications for ≥ 3 months

Exclusion criteria

Intolerance to drug class
Mini-Mental Status Examination <26/30
No observable episodes of freezing of gait despite common visual cues
Not on stable PD medications for 3 months
Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
Current use of monoamine oxidase inhibitor (MAO-I)
Hypersensitivity to drug class
Narrow angle glaucoma
Pheochromocytoma
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).
Patients with uncontrolled hypertension.
Patients with a history of symptomatic tachyarrhythmias.
Presence of uncontrolled depression and suicidal ideation.

Treatment and study plan

ATM FOG in PD

Drug

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

Primary outcomes

Number of Participants With Treatment Emergent Adverse Events

Time frame: week 8

Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Acronym: ATMFOG

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Aug 29, 2018
Registry last updated: Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed