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PharmacoMRI of Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01528592
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : December 24, 2013
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Darren Gitelman, Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Parkinson's Disease
Intervention Drug: Carbidopa-Levodopa
Enrollment 18
Recruitment Details Recruitment period: 12/1/2011 - 4/30/2012 Location: Medical clinic in Chicago
Pre-assignment Details  
Arm/Group Title On / Off Medication
Hide Arm/Group Description Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title On / Off Medication
Hide Arm/Group Description Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Patients with Parkinson's disease on dopaminergic therapy.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  61.1%
>=65 years
7
  38.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
66.22  (8.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.
Hide Description Correlation coefficient between UPDRS III score and independent components analysis network strength in left parietal cortex. UPDRS III is the Unified Parkinson's Disease Rating Scale composite motor score.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title On / Off Medication
Hide Arm/Group Description:
Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: unitless
0.5869
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title On / Off Medication
Hide Arm/Group Description Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
All-Cause Mortality
On / Off Medication
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
On / Off Medication
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
On / Off Medication
Affected / at Risk (%)
Total   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Darren Gitelman, MD
Organization: Northwestern University
Phone: 312-908-8266
Responsible Party: Darren Gitelman, Northwestern University
ClinicalTrials.gov Identifier: NCT01528592     History of Changes
Other Study ID Numbers: Ruby-60029592
First Submitted: January 31, 2012
First Posted: February 8, 2012
Results First Submitted: November 6, 2013
Results First Posted: December 24, 2013
Last Update Posted: May 3, 2018