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Treatment of Executive Dysfunction in Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286949
First Posted: February 6, 2006
Last Update Posted: September 18, 2017
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.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: March 11, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: Drug: Atomoxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Parkinson's disease (PD) outpatients (recruited 2005-2008 via Johns Hopkins clinics and community) had clinically significant Executive Dysfunction, defined as moderately severe problems with disorganization, distractibility, task completion, planning or problem solving that impaired function, were a decline from pre-PD, and verified by informant.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects were assigned to and received open label atomoxetine.

Reporting Groups
  Description
Atomoxetine Open Label This open-label, uncontrolled, single arm, flexible dose trial consisted of atomoxetine (Strattera) in 25 mg capsules initiated at 25 mg/day in the morning (Week 1) and advancing to 50mg/at (weeks 2-4), 75 mg/day (Week 5), and 100 mg/day (Weeks 6-8). Dose reductions were allowed to a minimum of 2.5 mg/day for intolerance.

Participant Flow:   Overall Study
    Atomoxetine Open Label
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled subjects

Reporting Groups
  Description
Atomoxetine Atomoxetine (Strattera): Open label, no comparator

Baseline Measures
   Atomoxetine 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      12 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.3  (7.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  58.3% 
Male      5  41.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Global Impression of Change-Clinician Rated Score (CGIC-C)   [ Time Frame: 8 weeks ]

2.  Primary:   Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale   [ Time Frame: baseline and 8 weeks ]

3.  Primary:   Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data interpretation limited by open-label uncontrolled design, small sample size, subjects young (< age 65 years); multiple comparisons, intersubject variability, possible inclusion bias, ceiling and practice effects for neuropsychological data.


  More Information
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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: Laura Marsh, M.D., Principal Investigator
Organization: Michael E. DeBakey VA Medical Center
phone: 713-794-8907
e-mail: laura.marsh2@va.gov


Publications of Results:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00286949     History of Changes
Other Study ID Numbers: WIRB#20040223
B4Z-US-X029 ( Other Identifier: Eli Lilly Investigator-Initiated Grants Program )
First Submitted: February 3, 2006
First Posted: February 6, 2006
Results First Submitted: March 11, 2014
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017