Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00321854
First received: May 3, 2006
Last updated: May 7, 2014
Last verified: March 2014
Results First Received: December 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson Disease
Intervention: Drug: pramipexole

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Early Pramipexole Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
Delayed Pramipexole Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.

Participant Flow:   Overall Study
    Early Pramipexole     Delayed Pramipexole  
STARTED     261     274  
COMPLETED     198     192  
NOT COMPLETED     63     82  
Adverse Event                 41                 43  
Lack of Efficacy                 9                 14  
Protocol Violation                 6                 5  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 6                 17  
Unknown                 1                 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.
No text entered.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Total Total of all reporting groups

Baseline Measures
    Early Pramipexole     Delayed Pramipexole     Total  
Number of Participants  
[units: participants]
  261     274     535  
Age [1]
[units: Years]
Mean ± Standard Deviation
  62.1  ± 10.1     62.9  ± 9.9     62.5  ± 10  
Gender [1]
[units: participants]
     
Female     84     108     192  
Male     177     166     343  
[1] Treated set (TS)



  Outcome Measures
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1.  Primary:   Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Primary
Measure Title Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
Measure Description The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     200  
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.3  ± 0.7     0.7  ± 0.7  


Statistical Analysis 1 for Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.6503
Mean Difference (Net) [4] -0.4
Standard Error of the mean ± 0.9
95% Confidence Interval ( -2.2 to 1.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
Measure Description The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.6  ± 0.7     0.5  ± 0.7  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.9568
Mean Difference (Net) [4] 0.0
Standard Error of the mean ± 0.9
95% Confidence Interval ( -1.7 to 1.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
Measure Description The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.5  ± 0.6     4.3  ± 0.6  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -4.8
Standard Error of the mean ± 0.8
95% Confidence Interval ( -6.3 to -3.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
Measure Description The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time Frame Baseline and Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -1.8  ± 0.6     2.6  ± 0.6  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -4.4
Standard Error of the mean ± 0.7
95% Confidence Interval ( -5.8 to -3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
Measure Description The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time Frame Baseline and Month 3  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     198  
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -2.9  ± 0.5     -0.1  ± 0.5  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -2.9
Standard Error of the mean ± 0.6
95% Confidence Interval ( -4.1 to -1.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
Measure Description The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     200  
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.6  ± 0.7     0.7  ± 0.7  


Statistical Analysis 1 for Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.8693
Mean Difference (Net) [4] -0.1
Standard Error of the mean ± 0.9
95% Confidence Interval ( -1.8 to 1.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
Measure Description The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.8  ± 0.7     0.6  ± 0.7  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.8155
Mean Difference (Net) [4] 0.2
Standard Error of the mean ± 0.9
95% Confidence Interval ( -1.5 to 1.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



8.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
Measure Description The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.3  ± 0.6     4.2  ± 0.6  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -4.5
Standard Error of the mean ± 0.8
95% Confidence Interval ( -6 to -3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



9.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6   [ Time Frame: Baseline and Month 6 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
Measure Description The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time Frame Baseline and Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -1.5  ± 0.6     2.5  ± 0.6  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -4
Standard Error of the mean ± 0.7
95% Confidence Interval ( -5.4 to -2.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



10.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3   [ Time Frame: Baseline and Month 3 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
Measure Description The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time Frame Baseline and Month 3  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     198  
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -2.8  ± 0.5     0.0  ± 0.5  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -2.8
Standard Error of the mean ± 0.6
95% Confidence Interval ( -3.9 to -1.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



11.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
Measure Description The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     200  
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.1  ± 0.5     0.3  ± 0.5  


Statistical Analysis 1 for Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.7999
Mean Difference (Net) [4] -0.2
Standard Error of the mean ± 0.7
95% Confidence Interval ( -1.5 to 1.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



12.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
Measure Description The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.2  ± 0.5     -0.1  ± 0.5  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.7395
Mean Difference (Net) [4] 0.2
Standard Error of the mean ± 0.7
95% Confidence Interval ( -1.1 to 1.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



13.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
Measure Description The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.6  ± 0.5     2.7  ± 0.5  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -3.3
Standard Error of the mean ± 0.6
95% Confidence Interval ( -4.5 to -2.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6   [ Time Frame: Baseline and Month 6 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
Measure Description The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time Frame Baseline and Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -1.6  ± 0.4     1.3  ± 0.4  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -2.9
Standard Error of the mean ± 0.6
95% Confidence Interval ( -4 to -1.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



15.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3   [ Time Frame: Baseline and Month 3 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
Measure Description The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time Frame Baseline and Month 3  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     198  
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -2.1  ± 0.4     -0.3  ± 0.4  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0002
Mean Difference (Net) [4] -1.8
Standard Error of the mean ± 0.5
95% Confidence Interval ( -2.7 to -0.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



16.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
Measure Description The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     200  
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.5  ± 0.2     0.4  ± 0.2  


Statistical Analysis 1 for Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.9256
Mean Difference (Net) [4] 0
Standard Error of the mean ± 0.3
95% Confidence Interval ( -0.6 to 0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



17.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
Measure Description The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.6  ± 0.2     0.6  ± 0.2  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.9792
Mean Difference (Net) [4] 0
Standard Error of the mean ± 0.3
95% Confidence Interval ( -0.6 to 0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



18.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
Measure Description The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.4  ± 0.2     1.5  ± 0.2  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0001
Mean Difference (Net) [4] -1.1
Standard Error of the mean ± 0.3
95% Confidence Interval ( -1.7 to -0.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



19.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6   [ Time Frame: Baseline and Month 6 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
Measure Description The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time Frame Baseline and Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  0.1  ± 0.2     1.2  ± 0.2  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -1.1
Standard Error of the mean ± 0.3
95% Confidence Interval ( -1.6 to -0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



20.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3   [ Time Frame: Baseline and Month 3 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
Measure Description The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time Frame Baseline and Month 3  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     198  
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.7  ± 0.2     0.3  ± 0.2  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] -1
Standard Error of the mean ± 0.2
95% Confidence Interval ( -1.5 to -0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



21.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
Measure Description The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     200  
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.3  ± 0.1     0  ± 0.1  


Statistical Analysis 1 for Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0376
Mean Difference (Net) [4] -0.3
Standard Error of the mean ± 0.1
95% Confidence Interval ( -0.5 to 0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



22.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
Measure Description The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.2  ± 0.1     -0.1  ± 0.1  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.1607
Mean Difference (Net) [4] -0.2
Standard Error of the mean ± 0.1
95% Confidence Interval ( -0.4 to 0.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



23.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
Measure Description The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.2  ± 0.1     0.1  ± 0.1  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0173
Mean Difference (Net) [4] -0.3
Standard Error of the mean ± 0.1
95% Confidence Interval ( -0.5 to -0.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



24.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
Measure Description The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time Frame Baseline and Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.3  ± 0.1     0.1  ± 0.1  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0007
Mean Difference (Net) [4] -0.4
Standard Error of the mean ± 0.1
95% Confidence Interval ( -0.6 to -0.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



25.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]

Measure Type Secondary
Measure Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
Measure Description The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time Frame Baseline and Month 3  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     198  
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -0.2  ± 0.1     -0.1  ± 0.1  


Statistical Analysis 1 for Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.4381
Mean Difference (Net) [4] -0.1
Standard Error of the mean ± 0.1
95% Confidence Interval ( -0.3 to 0.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



26.  Secondary:   Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15   [ Time Frame: Month 15 ]

Measure Type Secondary
Measure Title Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
Measure Description The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.
Time Frame Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  200     184  
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15  
[units: Participants]
  18     21  


Statistical Analysis 1 for Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.5116
Odds Ratio (OR) [4] 0.796
95% Confidence Interval ( 0.403 to 1.573 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



27.  Secondary:   Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Measure Description The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  209     198  
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15  
[units: Participants]
   
Improved     4     3  
Essentially unchanged     200     191  
Worsened     5     4  


Statistical Analysis 1 for Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.7913
Odds Ratio (OR) [4] 1.153
95% Confidence Interval ( 0.403 to 3.299 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



28.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
Measure Description The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     197  
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -1  ± 0.3     -0.5  ± 0.3  


Statistical Analysis 1 for Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.1702
Mean Difference (Net) [4] -0.5
Standard Error of the mean ± 0.4
95% Confidence Interval ( -1.3 to 0.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



29.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
Measure Description The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     199  
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -1.1  ± 0.3     0.3  ± 0.3  


Statistical Analysis 1 for Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0009
Mean Difference (Net) [4] -1.4
Standard Error of the mean ± 0.4
95% Confidence Interval ( -2.2 to -0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



30.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]

Measure Type Secondary
Measure Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
Measure Description The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame Baseline and Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     199  
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -1.2  ± 0.3     0.2  ± 0.3  


Statistical Analysis 1 for Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0005
Mean Difference (Net) [4] -1.4
Standard Error of the mean ± 0.4
95% Confidence Interval ( -2.1 to -0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



31.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]

Measure Type Secondary
Measure Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
Measure Description The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame Baseline and Month 3  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     198  
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3  
[units: Units on a scale]
Least Squares Mean ± Standard Error
  -1  ± 0.3     -0.3  ± 0.3  


Statistical Analysis 1 for Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0422
Mean Difference (Net) [4] -0.7
Standard Error of the mean ± 0.3
95% Confidence Interval ( -1.4 to 0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



32.  Secondary:   Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
Measure Description The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     200  
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15  
[units: Units on a scale]
Median ( Inter-Quartile Range )
  -0.4  
  ( -3.2 to 3.8 )  
  0.3  
  ( -3.6 to 4.4 )  


Statistical Analysis 1 for Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.2149
Median Difference (Net) [4] -0.573
95% Confidence Interval ( -1.823 to 0.677 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



33.  Secondary:   Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
Measure Description The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  209     199  
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9  
[units: Units on a scale]
Median ( Inter-Quartile Range )
  -0.5  
  ( -3.6 to 2.0 )  
  1.4  
  ( -2.2 to 5.0 )  


Statistical Analysis 1 for Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.0001
Median Difference (Net) [4] -2.031
95% Confidence Interval ( -3.125 to -0.938 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



34.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
Measure Description The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     200  
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15  
[units: Units on a scale]
Median ( Inter-Quartile Range )
  0  
  ( -0.026 to 0.092 )  
  0  
  ( -0.079 to 0.078 )  


Statistical Analysis 1 for Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.2605
Median Difference (Net) [4] 0
95% Confidence Interval ( 0 to 0.026 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



35.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
Measure Description The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  209     199  
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9  
[units: Units on a scale]
Median ( Inter-Quartile Range )
  0  
  ( -0.026 to 0.092 )  
  0  
  ( -0.140 to 0 )  


Statistical Analysis 1 for Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.0001
Median Difference (Net) [4] 0.051
95% Confidence Interval ( 0 to 0.089 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



36.  Secondary:   Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
Measure Description The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  210     199  
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15  
[units: Units on a scale]
Median ( Inter-Quartile Range )
  0  
  ( -8.0 to 7.0 )  
  0  
  ( -10.0 to 2.0 )  


Statistical Analysis 1 for Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.0489
Median Difference (Net) [4] 2
95% Confidence Interval ( 0 to 5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



37.  Secondary:   Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9   [ Time Frame: Baseline and Month 9 ]

Measure Type Secondary
Measure Title Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
Measure Description The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Time Frame Baseline and Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  208     198  
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9  
[units: Units on a scale]
Median ( Inter-Quartile Range )
  0  
  ( -5.5 to 5.0 )  
  -0.5  
  ( -10.0 to 5.0 )  


Statistical Analysis 1 for Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.0282
Median Difference (Net) [4] 3
95% Confidence Interval ( 0 to 5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



38.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time Frame Month 1  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     133  
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1  
[units: Participants]
   
No risk of gambling     146     133  
Risk of gambling     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1



39.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time Frame Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     134  
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6  
[units: Participants]
   
No risk of gambling     146     134  
Risk of gambling     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6



40.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9   [ Time Frame: Month 9 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time Frame Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     134  
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9  
[units: Participants]
   
No risk of gambling     146     134  
Risk of gambling     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9



41.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time Frame Month 12  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  143     128  
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12  
[units: Participants]
   
No risk of gambling     143     128  
Risk of gambling     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12



42.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15   [ Time Frame: Month 15 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time Frame Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  145     132  
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15  
[units: Participants]
   
No risk of gambling     145     132  
Risk of gambling     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15



43.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time Frame Month 1  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     133  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1  
[units: Participants]
   
No compulsive sexual behaviour     146     133  
Compulsive sexual behaviour     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1



44.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time Frame Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     134  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6  
[units: Participants]
   
No compulsive sexual behaviour     146     134  
Compulsive sexual behaviour     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6



45.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9   [ Time Frame: Month 9 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time Frame Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     134  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9  
[units: Participants]
   
No compulsive sexual behaviour     146     134  
Compulsive sexual behaviour     0     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9



46.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time Frame Month 12  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  143     128  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12  
[units: Participants]
   
No compulsive sexual behaviour     143     126  
Compulsive sexual behaviour     0     2  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12



47.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15   [ Time Frame: Month 15 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time Frame Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  145     132  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15  
[units: Participants]
   
No compulsive sexual behaviour     145     131  
Compulsive sexual behaviour     0     1  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15



48.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1   [ Time Frame: Month 1 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time Frame Month 1  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     133  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1  
[units: Participants]
   
No compulsive buying     145     133  
Compulsive buying     1     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1



49.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time Frame Month 6  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     134  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6  
[units: Participants]
   
No compulsive buying     144     134  
Compulsive buying     2     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6



50.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9   [ Time Frame: Month 9 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time Frame Month 9  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  146     134  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9  
[units: Participants]
   
No compulsive buying     143     134  
Compulsive buying     3     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9



51.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time Frame Month 12  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  143     128  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12  
[units: Participants]
   
No compulsive buying     141     128  
Compulsive buying     2     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12



52.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15   [ Time Frame: Month 15 ]

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time Frame Month 15  
Safety Issue No  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  145     132  
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15  
[units: Participants]
   
No compulsive buying     143     132  
Compulsive buying     2     0  

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15



53.  Secondary:   Percentage Change From Baseline in the Striatum Uptake at Month 15   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Percentage Change From Baseline in the Striatum Uptake at Month 15
Measure Description The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).
Time Frame Baseline and Month 15  
Safety Issue No  

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.
The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  62     61  
Percentage Change From Baseline in the Striatum Uptake at Month 15  
[units: Percentage change]
Least Squares Mean ± Standard Error
  -15.1  ± 2.1     -14.6  ± 2  


Statistical Analysis 1 for Percentage Change From Baseline in the Striatum Uptake at Month 15
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.8397
Mean Difference (Net) [4] -0.5
Standard Error of the mean ± 2.5
95% Confidence Interval ( -5.4 to 4.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



54.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Measure Description No text entered.
Time Frame Baseline and Month 15  
Safety Issue No  

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.
Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX

Reporting Groups
  Description
Early Pramipexole Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
Delayed Pramipexole Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  211     209  
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes  
[units: percentage of participants]
   
Haematocrit - decrease     1.4     1.0  
Haemoglobin - decrease     2.3     0.9  
MCV - increase     0.5     0  
Sodium - decrease     1.4     0.5  
Calcium - increase     0     0.5  
Chloride - decrease     0.9     0  
Phosphate - decrease     1.0     0  
Phosphate - increase     0.5     0  

No statistical analysis provided for Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes



55.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Measure Description No text entered.
Time Frame Baseline and Month 15  
Safety Issue No  

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.
Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX

Reporting Groups
  Description
Early Pramipexole Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
Delayed Pramipexole Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  214     209  
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes  
[units: percentage of participants]
   
GGT - increase     0.5     0  
Amylase - increase     1.4     0  

No statistical analysis provided for Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes



56.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Measure Description No text entered.
Time Frame Baseline and Month 15  
Safety Issue No  

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.
Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX.

Reporting Groups
  Description
Early Pramipexole Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
Delayed Pramipexole Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  214     209  
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates  
[units: percentage of participants]
   
Glucose - decrease     0     2.2  
Glucose - increase     3.6     0  
Cholesterol - increase     1.4     2.9  
Blood Urea Nitrogen - increase     0.9     0.5  
Creatinine - increase     0.5     1.0  
Triglyceride - increase     1.4     0  
Uric acid - increase     0.5     0.5  

No statistical analysis provided for Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates



57.  Secondary:   Clinically Significant Abnormalities in Vital Signs   [ Time Frame: Baseline and Month 15 ]

Measure Type Secondary
Measure Title Clinically Significant Abnormalities in Vital Signs
Measure Description No text entered.
Time Frame Baseline and Month 15  
Safety Issue No  

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.
Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX.

Reporting Groups
  Description
Early Pramipexole Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
Delayed Pramipexole Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.

Measured Values
    Early Pramipexole     Delayed Pramipexole  
Number of Participants Analyzed  
[units: participants]
  261     274  
Clinically Significant Abnormalities in Vital Signs  
[units: percentage of participants]
   
Sinus bradycardia     0     0.4  
Hypotension     0     0.5  

No statistical analysis provided for Clinically Significant Abnormalities in Vital Signs




  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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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00321854     History of Changes
Other Study ID Numbers: 248.595
Study First Received: May 3, 2006
Results First Received: December 18, 2009
Last Updated: May 7, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna, Austria
Finland: Finnish Medicines Agency
France: AFFSAPS
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Comitato Etico dell'Az. USL 12 di Viareggio - VIAREGGIO
Japan: Ministry of Health, Labor and Welfare
Spain: Spanish Agency for Medicines and Health Products
Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden
United States: Food and Drug Administration