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

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ClinicalTrials.gov Identifier: NCT00321854
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : January 26, 2010
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson Disease
Intervention Drug: pramipexole
Enrollment 535

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 261 274
Completed 198 192
Not Completed 63 82
Reason Not Completed
Adverse Event             41             43
Lack of Efficacy             9             14
Protocol Violation             6             5
Lost to Follow-up             0             2
Withdrawal by Subject             6             17
Other             1             1
Arm/Group Title Early Pramipexole Delayed Pramipexole Total
Hide Arm/Group Description 1.5 milligrams/day pramipexole (for up to 15 months) Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) Total of all reporting groups
Overall Number of Baseline Participants 261 274 535
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 261 participants 274 participants 535 participants
62.1  (10.1) 62.9  (9.9) 62.5  (10)
[1]
Measure Description: Treated set (TS)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 274 participants 535 participants
Female
84
  32.2%
108
  39.4%
192
  35.9%
Male
177
  67.8%
166
  60.6%
343
  64.1%
[1]
Measure Description: Treated set (TS)
1.Primary Outcome
Title Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.3  (0.7) 0.7  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6503
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval 95%
-2.2 to 1.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.6  (0.7) 0.5  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9568
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval 95%
-1.7 to 1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.5  (0.6) 4.3  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.8
Confidence Interval 95%
-6.3 to -3.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.8  (0.6) 2.6  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.4
Confidence Interval 95%
-5.8 to -3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 198
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.9  (0.5) -0.1  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.9
Confidence Interval 95%
-4.1 to -1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.6  (0.7) 0.7  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8693
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval 95%
-1.8 to 1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.8  (0.7) 0.6  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8155
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval 95%
-1.5 to 1.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.3  (0.6) 4.2  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.5
Confidence Interval 95%
-6 to -3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.5  (0.6) 2.5  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4
Confidence Interval 95%
-5.4 to -2.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 198
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.8  (0.5) 0.0  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.8
Confidence Interval 95%
-3.9 to -1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.1  (0.5) 0.3  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7999
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval 95%
-1.5 to 1.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.2  (0.5) -0.1  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7395
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval 95%
-1.1 to 1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.6  (0.5) 2.7  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.3
Confidence Interval 95%
-4.5 to -2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.6  (0.4) 1.3  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.9
Confidence Interval 95%
-4 to -1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 198
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.1  (0.4) -0.3  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval 95%
-2.7 to -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.5
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.5  (0.2) 0.4  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9256
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval 95%
-0.6 to 0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.6  (0.2) 0.6  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9792
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval 95%
-0.6 to 0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.4  (0.2) 1.5  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1
Confidence Interval 95%
-1.7 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.1  (0.2) 1.2  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1
Confidence Interval 95%
-1.6 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 198
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.7  (0.2) 0.3  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1
Confidence Interval 95%
-1.5 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.3  (0.1) 0  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0376
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval 95%
-0.5 to 0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.2  (0.1) -0.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1607
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval 95%
-0.4 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.2  (0.1) 0.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0173
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval 95%
-0.5 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.3  (0.1) 0.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval 95%
-0.6 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 198
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.2  (0.1) -0.1  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4381
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval 95%
-0.3 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 200 184
Measure Type: Number
Unit of Measure: Participants
18 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5116
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.796
Confidence Interval 95%
0.403 to 1.573
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 209 198
Measure Type: Number
Unit of Measure: Participants
Improved 4 3
Essentially unchanged 200 191
Worsened 5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7913
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.153
Confidence Interval 95%
0.403 to 3.299
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 197
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1  (0.3) -0.5  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1702
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval 95%
-1.3 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 199
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.1  (0.3) 0.3  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Confidence Interval 95%
-2.2 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 199
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.2  (0.3) 0.2  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Confidence Interval 95%
-2.1 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 198
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1  (0.3) -0.3  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0422
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval 95%
-1.4 to 0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 211 200
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
-0.4
(-3.2 to 3.8)
0.3
(-3.6 to 4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2149
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.573
Confidence Interval 95%
-1.823 to 0.677
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 209 199
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
-0.5
(-3.6 to 2.0)
1.4
(-2.2 to 5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -2.031
Confidence Interval 95%
-3.125 to -0.938
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 200
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
0
(-0.026 to 0.092)
0
(-0.079 to 0.078)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2605
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0
Confidence Interval 95%
0 to 0.026
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 209 199
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
0
(-0.026 to 0.092)
0
(-0.140 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.051
Confidence Interval 95%
0 to 0.089
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 210 199
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
0
(-8.0 to 7.0)
0
(-10.0 to 2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0489
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 2
Confidence Interval 95%
0 to 5
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 208 198
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
0
(-5.5 to 5.0)
-0.5
(-10.0 to 5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0282
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 3
Confidence Interval 95%
0 to 5
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 133
Measure Type: Number
Unit of Measure: Participants
No risk of gambling 146 133
Risk of gambling 0 0
39.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 134
Measure Type: Number
Unit of Measure: Participants
No risk of gambling 146 134
Risk of gambling 0 0
40.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 134
Measure Type: Number
Unit of Measure: Participants
No risk of gambling 146 134
Risk of gambling 0 0
41.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 143 128
Measure Type: Number
Unit of Measure: Participants
No risk of gambling 143 128
Risk of gambling 0 0
42.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 145 132
Measure Type: Number
Unit of Measure: Participants
No risk of gambling 145 132
Risk of gambling 0 0
43.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 133
Measure Type: Number
Unit of Measure: Participants
No compulsive sexual behaviour 146 133
Compulsive sexual behaviour 0 0
44.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 134
Measure Type: Number
Unit of Measure: Participants
No compulsive sexual behaviour 146 134
Compulsive sexual behaviour 0 0
45.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 134
Measure Type: Number
Unit of Measure: Participants
No compulsive sexual behaviour 146 134
Compulsive sexual behaviour 0 0
46.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 143 128
Measure Type: Number
Unit of Measure: Participants
No compulsive sexual behaviour 143 126
Compulsive sexual behaviour 0 2
47.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 145 132
Measure Type: Number
Unit of Measure: Participants
No compulsive sexual behaviour 145 131
Compulsive sexual behaviour 0 1
48.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 133
Measure Type: Number
Unit of Measure: Participants
No compulsive buying 145 133
Compulsive buying 1 0
49.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 134
Measure Type: Number
Unit of Measure: Participants
No compulsive buying 144 134
Compulsive buying 2 0
50.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 146 134
Measure Type: Number
Unit of Measure: Participants
No compulsive buying 143 134
Compulsive buying 3 0
51.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 143 128
Measure Type: Number
Unit of Measure: Participants
No compulsive buying 141 128
Compulsive buying 2 0
52.Secondary Outcome
Title Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 145 132
Measure Type: Number
Unit of Measure: Participants
No compulsive buying 143 132
Compulsive buying 2 0
53.Secondary Outcome
Title Percentage Change From Baseline in the Striatum Uptake at Month 15
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
1.5 milligrams/day pramipexole (for up to 15 months)
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Overall Number of Participants Analyzed 62 61
Least Squares Mean (Standard Error)
Unit of Measure: Percentage change
-15.1  (2.1) -14.6  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Pramipexole, Delayed Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8397
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval 95%
-5.4 to 4.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.5
Estimation Comments [Not Specified]
54.Secondary Outcome
Title Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Hide Description [Not Specified]
Time Frame Baseline and Month 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 211 209
Measure Type: Number
Unit of Measure: 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
55.Secondary Outcome
Title Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Hide Description [Not Specified]
Time Frame Baseline and Month 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 214 209
Measure Type: Number
Unit of Measure: percentage of participants
GGT - increase 0.5 0
Amylase - increase 1.4 0
56.Secondary Outcome
Title Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Hide Description [Not Specified]
Time Frame Baseline and Month 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 214 209
Measure Type: Number
Unit of Measure: 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
57.Secondary Outcome
Title Clinically Significant Abnormalities in Vital Signs
Hide Description [Not Specified]
Time Frame Baseline and Month 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 261 274
Measure Type: Number
Unit of Measure: percentage of participants
Sinus bradycardia 0 0.4
Hypotension 0 0.5
Time Frame Onset date after the date of first dose up to 48 hours after last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Pramipexole Delayed Pramipexole
Hide Arm/Group Description 1.5 milligrams/day pramipexole (for up to 15 months) Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
All-Cause Mortality
Early Pramipexole Delayed Pramipexole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Early Pramipexole Delayed Pramipexole
Affected / at Risk (%) Affected / at Risk (%)
Total   25/261 (9.58%)   25/274 (9.12%) 
Cardiac disorders     
Acute coronary syndrome  1  0/261 (0.00%)  1/274 (0.36%) 
Angina pectoris  1  0/261 (0.00%)  1/274 (0.36%) 
Angina unstable  1  1/261 (0.38%)  0/274 (0.00%) 
Cardiac failure  1  0/261 (0.00%)  1/274 (0.36%) 
Cardiac failure congestive  1  1/261 (0.38%)  1/274 (0.36%) 
Coronary artery disease  1  1/261 (0.38%)  1/274 (0.36%) 
Mitral valve incompetence  1  0/261 (0.00%)  1/274 (0.36%) 
Palpitations  1  1/261 (0.38%)  0/274 (0.00%) 
Sinus bradycardia  1  0/261 (0.00%)  1/274 (0.36%) 
Ventricular tachycardia  1  1/261 (0.38%)  0/274 (0.00%) 
Congenital, familial and genetic disorders     
Hydrocele  1  0/261 (0.00%)  1/274 (0.36%) 
Ear and labyrinth disorders     
Deafness  1  1/261 (0.38%)  0/274 (0.00%) 
Eye disorders     
Macular hole  1  1/261 (0.38%)  0/274 (0.00%) 
Pterygium  1  1/261 (0.38%)  0/274 (0.00%) 
Gastrointestinal disorders     
Duodenal ulcer  1  1/261 (0.38%)  0/274 (0.00%) 
Inguinal hernia  1  1/261 (0.38%)  0/274 (0.00%) 
Small intestine obstruction  1  1/261 (0.38%)  0/274 (0.00%) 
Subileus  1  0/261 (0.00%)  1/274 (0.36%) 
General disorders     
Chest pain  1  1/261 (0.38%)  0/274 (0.00%) 
Hyperplasia  1  0/261 (0.00%)  1/274 (0.36%) 
Pyrexia  1  0/261 (0.00%)  1/274 (0.36%) 
Hepatobiliary disorders     
Cholecystitis  1  0/261 (0.00%)  1/274 (0.36%) 
Infections and infestations     
Urinary tract infection  1  0/261 (0.00%)  2/274 (0.73%) 
Bacterial infection  1  1/261 (0.38%)  0/274 (0.00%) 
Gastroenteristis  1  1/261 (0.38%)  0/274 (0.00%) 
Influenza  1  1/261 (0.38%)  0/274 (0.00%) 
Localised infection  1  1/261 (0.38%)  0/274 (0.00%) 
Respiratory tract infection  1  0/261 (0.00%)  1/274 (0.36%) 
Sepsis  1  0/261 (0.00%)  1/274 (0.36%) 
Staphylococcal infection  1  0/261 (0.00%)  1/274 (0.36%) 
Subcutaneous abscess  1  0/261 (0.00%)  1/274 (0.36%) 
Injury, poisoning and procedural complications     
Facial bones fracture  1  0/261 (0.00%)  1/274 (0.36%) 
Fall  1  1/261 (0.38%)  1/274 (0.36%) 
Radial nerve injury  1  1/261 (0.38%)  0/274 (0.00%) 
Subdural haematoma  1  0/261 (0.00%)  1/274 (0.36%) 
Metabolism and nutrition disorders     
Dehydration  1  0/261 (0.00%)  1/274 (0.36%) 
Hypoglycaemia  1  0/261 (0.00%)  1/274 (0.36%) 
Musculoskeletal and connective tissue disorders     
Foot deformity  1  1/261 (0.38%)  0/274 (0.00%) 
Musculoskeletal chest pain  1  1/261 (0.38%)  0/274 (0.00%) 
Osteoarthritis  1  1/261 (0.38%)  0/274 (0.00%) 
Rhabdomyolysis  1  1/261 (0.38%)  0/274 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/261 (0.00%)  2/274 (0.73%) 
Large cell carcinoma of the respiratory tract stage unspecified  1  1/261 (0.38%)  0/274 (0.00%) 
Lung neoplasm malignant  1  1/261 (0.38%)  0/274 (0.00%) 
Mesothelioma  1  0/261 (0.00%)  1/274 (0.36%) 
Multiple myeloma  1  0/261 (0.00%)  1/274 (0.36%) 
Ovarian neoplasm  1  0/261 (0.00%)  1/274 (0.36%) 
Nervous system disorders     
Transient ischaemic attack  1  2/261 (0.77%)  1/274 (0.36%) 
Epilepsy  1  0/261 (0.00%)  1/274 (0.36%) 
Loss of consciousness  1  1/261 (0.38%)  0/274 (0.00%) 
Pakinson's disease  1  1/261 (0.38%)  1/274 (0.36%) 
Pakinsonism  1  1/261 (0.38%)  0/274 (0.00%) 
Peroneal nerve palsy  1  1/261 (0.38%)  0/274 (0.00%) 
Presyncope  1  1/261 (0.38%)  0/274 (0.00%) 
Sciatica  1  1/261 (0.38%)  0/274 (0.00%) 
Syncope  1  1/261 (0.38%)  0/274 (0.00%) 
Psychiatric disorders     
Hallucination  1  2/261 (0.77%)  0/274 (0.00%) 
Anxiety  1  0/261 (0.00%)  1/274 (0.36%) 
Completed suicide  1  0/261 (0.00%)  1/274 (0.36%) 
Confusional state  1  1/261 (0.38%)  1/274 (0.36%) 
Renal and urinary disorders     
Dysuria  1  0/261 (0.00%)  1/274 (0.36%) 
Renal failure acute  1  1/261 (0.38%)  0/274 (0.00%) 
Reproductive system and breast disorders     
Breast disorder  1  1/261 (0.38%)  0/274 (0.00%) 
Varicocele  1  0/261 (0.00%)  1/274 (0.36%) 
Vascular disorders     
Orthostatic hypotension  1  0/261 (0.00%)  1/274 (0.36%) 
Peripheral arterial occulsive disease  1  0/261 (0.00%)  1/274 (0.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Pramipexole Delayed Pramipexole
Affected / at Risk (%) Affected / at Risk (%)
Total   172/261 (65.90%)   164/274 (59.85%) 
Gastrointestinal disorders     
Nausea  1  62/261 (23.75%)  49/274 (17.88%) 
Constipation  1  19/261 (7.28%)  28/274 (10.22%) 
Diarrhoea  1  10/261 (3.83%)  22/274 (8.03%) 
General disorders     
Fatigue  1  36/261 (13.79%)  38/274 (13.87%) 
Oedema peripheral  1  25/261 (9.58%)  13/274 (4.74%) 
Infections and infestations     
Nasopharyngitis  1  19/261 (7.28%)  24/274 (8.76%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  24/261 (9.20%)  18/274 (6.57%) 
Arthralgia  1  17/261 (6.51%)  6/274 (2.19%) 
Nervous system disorders     
Somnolence  1  36/261 (13.79%)  21/274 (7.66%) 
Dizziness  1  35/261 (13.41%)  33/274 (12.04%) 
Headache  1  20/261 (7.66%)  28/274 (10.22%) 
Psychiatric disorders     
Insomnia  1  26/261 (9.96%)  21/274 (7.66%) 
Depression  1  18/261 (6.90%)  16/274 (5.84%) 
Sleep disorder  1  14/261 (5.36%)  6/274 (2.19%) 
Abnormal dreams  1  8/261 (3.07%)  14/274 (5.11%) 
Vascular disorders     
Hypertension  1  11/261 (4.21%)  16/274 (5.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00321854     History of Changes
Other Study ID Numbers: 248.595
First Submitted: May 3, 2006
First Posted: May 4, 2006
Results First Submitted: December 18, 2009
Results First Posted: January 26, 2010
Last Update Posted: May 16, 2014