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Atomoxetine for Freezing of Gait in Parkinson's Disease (ATMFOG)

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ClinicalTrials.gov Identifier: NCT03651856
Recruitment Status : Completed
First Posted : August 29, 2018
Results First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Freezing of Gait Drug: ATM FOG in PD Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
Study Start Date : January 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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Arm Intervention/treatment
Experimental: Atomoxetine
Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off
Drug: ATM FOG in PD
open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651856


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Gonzalo J Revuelta, DO Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03651856     History of Changes
Other Study ID Numbers: Pro00014009
First Posted: August 29, 2018    Key Record Dates
Results First Posted: November 28, 2018
Last Update Posted: November 28, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs