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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Parkinson's Disease
Freezing of Gait
Intervention Drug: ATM FOG in PD
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atomoxetine
Hide Arm/Group Description

Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off

ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Atomoxetine
Hide Arm/Group Description

Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off

ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
67.1  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Count of Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atomoxetine
Hide Arm/Group Description:

Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off

ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Increase in Creatine
3
  30.0%
Worsening Fog (Freezing of Gait)
1
  10.0%
Diarrhea
1
  10.0%
Worsening Dyskinesia
1
  10.0%
Nausea
1
  10.0%
Mild Jitters
1
  10.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine
Hide Arm/Group Description

Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off

ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

All-Cause Mortality
Atomoxetine
Affected / at Risk (%)
Total   0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atomoxetine
Affected / at Risk (%) # Events
Total   8/10 (80.00%)    
Blood and lymphatic system disorders   
Increase in Creatine   3/10 (30.00%)  3
Gastrointestinal disorders   
Diarrhea   1/10 (10.00%)  1
General disorders   
Nausea *  1/10 (10.00%)  1
Nervous system disorders   
Worsening Fog (Freezing of Gait)   1/10 (10.00%)  1
Worsening Dyskinesia   1/10 (10.00%)  1
Mild Jitters   1/10 (10.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Gonzalo Revuelta
Organization: Medical University of SC
Phone: 843-792-7262
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03651856     History of Changes
Other Study ID Numbers: Pro00014009
First Submitted: July 2, 2018
First Posted: August 29, 2018
Results First Submitted: October 2, 2018
Results First Posted: November 28, 2018
Last Update Posted: November 28, 2018