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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

Tracking Information
First Submitted Date  ICMJE July 2, 2018
First Posted Date  ICMJE August 29, 2018
Results First Submitted Date  ICMJE October 2, 2018
Results First Posted Date  ICMJE November 28, 2018
Last Update Posted Date November 28, 2018
Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
Incidence of Treatment emergent adverse events [ Time Frame: week 8 ]
Evaluate the safety of ATM 40mg bid in PD patients with FOG
Change History Complete list of historical versions of study NCT03651856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atomoxetine for Freezing of Gait in Parkinson's Disease
Official Title  ICMJE A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Freezing of Gait
Intervention  ICMJE Drug: ATM FOG in PD
open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Study Arms  ICMJE Experimental: Atomoxetine
Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off
Intervention: Drug: ATM FOG in PD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2018)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03651856
Other Study ID Numbers  ICMJE Pro00014009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gonzalo J Revuelta, DO Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP