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Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression (ELLDOPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134784
First Posted: August 25, 2005
Last Update Posted: August 8, 2014
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:
United States Department of Defense
Information provided by (Responsible Party):
Kenneth Marek, MD, Institute for Neurodegenerative Disorders
Results First Submitted: October 7, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Parkinson Disease
Intervention: Drug: [123I]B-CIT SPECT imaging

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo group
Levodopa 150mg/Day Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging
Levodopa 300 mg/Day Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging
Levodopa 600 mg/Day Levodopa 600/day, [123I]ß-CIT and SPECT imaging

Participant Flow:   Overall Study
    Placebo   Levodopa 150mg/Day   Levodopa 300 mg/Day   Levodopa 600 mg/Day
STARTED   29   38   37   38 
COMPLETED   27   36   35   37 
NOT COMPLETED   2   2   2   1 
Withdrawal by Subject                2                2                2                1 



  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.
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Reporting Groups
  Description
Placebo Group Subjects on placebo
Levodopa 150mg/Day Subjects on 150mg/day of Levodopa
Levodopa 300 mg/Day Subjects on 300 mg/day of Levodopa
Levodopa 600 mg/Day Subjects on Levodopa 600 mg/day
Total Total of all reporting groups

Baseline Measures
   Placebo Group   Levodopa 150mg/Day   Levodopa 300 mg/Day   Levodopa 600 mg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   38   37   38   142 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Age of Subject in Years   63.9  (10.5)   64.5  (11.8)   63.1  (10.2)   62.3  (9.8)   63.4  (10.6) 
Gender, Customized 
[Units: Participants]
         
Female   7   15   8   11   41 
Male   22   23   29   27   101 


  Outcome Measures

1.  Primary:   Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images   [ Time Frame: 40 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: Institute for Neurodegenerative Disorders
phone: 203 401 4300
e-mail: kmarek@indd.org


Publications of Results:

Responsible Party: Kenneth Marek, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00134784     History of Changes
Other Study ID Numbers: Elldopa
First Submitted: August 23, 2005
First Posted: August 25, 2005
Results First Submitted: October 7, 2010
Results First Posted: August 8, 2014
Last Update Posted: August 8, 2014