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

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ClinicalTrials.gov Identifier: NCT00134784
Recruitment Status : Completed
First Posted : August 25, 2005
Results First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Kenneth Marek, MD, Institute for Neurodegenerative Disorders

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
Enrollment 142

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Levodopa 150mg/Day Levodopa 300 mg/Day Levodopa 600 mg/Day
Hide Arm/Group Description Placebo group Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging Levodopa 600/day, [123I]ß-CIT and SPECT imaging
Period Title: Overall Study
Started 29 38 37 38
Completed 27 36 35 37
Not Completed 2 2 2 1
Reason Not Completed
Withdrawal by Subject             2             2             2             1
Arm/Group Title Placebo Group Levodopa 150mg/Day Levodopa 300 mg/Day Levodopa 600 mg/Day Total
Hide Arm/Group Description Subjects on placebo Subjects on 150mg/day of Levodopa Subjects on 300 mg/day of Levodopa Subjects on Levodopa 600 mg/day Total of all reporting groups
Overall Number of Baseline Participants 29 38 37 38 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age of Subject in Years Number Analyzed 29 participants 38 participants 37 participants 38 participants 142 participants
63.9  (10.5) 64.5  (11.8) 63.1  (10.2) 62.3  (9.8) 63.4  (10.6)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 38 participants 37 participants 38 participants 142 participants
Female 7 15 8 11 41
Male 22 23 29 27 101
1.Primary Outcome
Title Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images
Hide Description The use of SPECT to measure striatal dopamine-transporter density with the use of [123I]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.
Time Frame 40 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Placebo Group Levodopa Levodopa 2 Levodopa 3
Hide Arm/Group Description:
Participants receiving placebo
Subjects on 150 mg/day of Levodopa
Subjects on 300 mg/day of Levodopa
Subjects on 600 mg/day of Levodopa
Overall Number of Participants Analyzed 29 33 37 36
Overall Number of Units Analyzed
Type of Units Analyzed: B-CIT Uptake
29 33 37 36
Mean (Standard Deviation)
Unit of Measure: percent change of B-CIT Uptake
-2.6  (11.3) -4.7  (10.8) -3.7  (9.1) -6.9  (8.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title I123BCIT
Hide Arm/Group Description [123I]ß CIT and SPECT imaging' .
All-Cause Mortality
I123BCIT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
I123BCIT
Affected / at Risk (%)
Total   0/142 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
I123BCIT
Affected / at Risk (%)
Total   0/142 (0.00%) 
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
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