Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00297778
First received: February 28, 2006
Last updated: March 6, 2014
Last verified: March 2014
Results First Received: May 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Parkinson Disease
Depression
Interventions: Drug: Pramipexole
Other: Placebo

  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
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Participant Flow:   Overall Study
    Placebo     Pramipexole  
STARTED     152     144  
COMPLETED     133     124  
NOT COMPLETED     19     20  
Adverse Event                 16                 10  
Withdrawal by Subject                 1                 5  
Lack of Efficacy                 2                 1  
Non-compliant with trial protocol                 0                 3  
Other                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
Total Total of all reporting groups

Baseline Measures
    Placebo     Pramipexole     Total  
Number of Participants  
[units: participants]
  152     144     296  
Age  
[units: Years]
Mean ± Standard Deviation
  66.6  ± 9.9     67.4  ± 9.0     67  ± 9.5  
Gender  
[units: participants]
     
Female     74     82     156  
Male     78     62     140  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Primary
Measure Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
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 Week 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 Full analysis set (FAS) made up of all randomised and treated participants with a baseline and at least one on-treatment assessment of the BDI. 9 participants from those randomised and treated were excluded due to insufficient BDI data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12  
[units: Score on scale]
Least Squares Mean ± Standard Error
  -4  ± 0.5     -5.9  ± 0.5  


Statistical Analysis 1 for Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0103
Mean Difference (Net) [4] -1.9
95% Confidence Interval ( -3.4 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.



2.  Secondary:   Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12   [ Time Frame: Week 12 ]

Measure Type Secondary
Measure Title Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
Measure Description BDI clinical response was defined as a reduction of ≥50% from baseline
Time Frame Week 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.
FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score).

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  147     139  
Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12  
[units: participants]
  27     38  


Statistical Analysis 1 for Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.0535
Odds Ratio (OR) [4] 1.758
95% Confidence Interval ( 0.992 to 3.115 )
[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 Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
Measure Description The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)
Time Frame Baseline and Week 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.
FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12  
[units: units on a scale]
Least Squares Mean ± Standard Error
  -1.7  ± 0.3     -2.5  ± 0.3  


Statistical Analysis 1 for Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0346
Mean Difference (Net) [4] -0.8
95% Confidence Interval ( -1.5 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.



4.  Secondary:   Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
Measure Description The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)
Time Frame Baseline and Week 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.
FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12  
[units: units on a scale]
Median ( Inter-Quartile Range )
  0  
  ( -2 to 0 )  
  0  
  ( -2 to 0 )  


Statistical Analysis 1 for Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.5244
Mean Difference (Net) [4] 0
95% Confidence Interval ( -1 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.



5.  Secondary:   Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
Measure Description The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)
Time Frame Baseline and Week 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.
FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12  
[units: units on a scale]
Median ( Inter-Quartile Range )
  -1  
  ( -1 to 0 )  
  -1  
  ( -2 to 0 )  


Statistical Analysis 1 for Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
Groups [1] All groups
Method [2] van Elteren (country stratification)
P Value [3] 0.141
Median Difference (Net) [4] 0
95% Confidence Interval ( 0 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.



6.  Secondary:   Change From Baseline in the UPDRS Part II Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the UPDRS Part II Total Score at Week 12
Measure Description Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)
Time Frame Baseline and Week 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.
FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Change From Baseline in the UPDRS Part II Total Score at Week 12  
[units: units on a scale]
Least Squares Mean ± Standard Error
  -1.2  ± 0.3     -2.4  ± 0.3  


Statistical Analysis 1 for Change From Baseline in the UPDRS Part II Total Score at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.003
Mean Difference (Net) [4] -1.2
95% Confidence Interval ( -1.9 to -0.4 )
[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.



7.  Secondary:   Change From Baseline in the UPDRS Part III Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the UPDRS Part III Total Score at Week 12
Measure Description The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)
Time Frame Baseline and Week 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.
FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     138  
Change From Baseline in the UPDRS Part III Total Score at Week 12  
[units: units on a scale]
Least Squares Mean ± Standard Error
  -2.2  ± 0.5     -4.4  ± 0.6  


Statistical Analysis 1 for Change From Baseline in the UPDRS Part III Total Score at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0034
Mean Difference (Net) [4] -2.2
95% Confidence Interval ( -3.7 to -0.7 )
[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.



8.  Secondary:   Change From Baseline in the UPDRS Part II+III Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the UPDRS Part II+III Total Score at Week 12
Measure Description The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)
Time Frame Baseline and Week 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.
FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     138  
Change From Baseline in the UPDRS Part II+III Total Score at Week 12  
[units: units on a scale]
Least Squares Mean ± Standard Error
  -3.4  ± 0.7     -6.8  ± 0.7  


Statistical Analysis 1 for Change From Baseline in the UPDRS Part II+III Total Score at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0007
Mean Difference (Net) [4] -3.4
95% Confidence Interval ( -5.4 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.



9.  Secondary:   Clinical Global Impressions of Global Improvement (CGI-I) at Week 12   [ Time Frame: Week 12 ]

Measure Type Secondary
Measure Title Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
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)
Time Frame Week 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.
FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Clinical Global Impressions of Global Improvement (CGI-I) at Week 12  
[units: units on a scale]
Median ( Full Range )
  3  
  ( 1 to 6 )  
  3  
  ( 1 to 6 )  


Statistical Analysis 1 for Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.006
Odds Ratio (OR) [4] 1.821
95% Confidence Interval ( 1.187 to 2.794 )
[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 Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
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 Week 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.
FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  127     108  
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12  
[units: units on a scale]
Median ( Inter-Quartile Range )
  -2.4  
  ( -8.9 to 2.6 )  
  -3.3  
  ( -8.9 to 0.3 )  


Statistical Analysis 1 for Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
Groups [1] All groups
Method [2] van Elteren (country stratification)
P Value [3] 0.1925
Median Difference (Net) [4] -1.3
95% Confidence Interval ( -3.3 to 0.8 )
[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.



11.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
Measure Description This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time Frame Baseline and Week 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.
FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  144     136  
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12  
[units: units on a scale]
Median ( Inter-Quartile Range )
  0  
  ( -0.06 to 0.12 )  
  0.07  
  ( 0 to 0.21 )  


Statistical Analysis 1 for Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
Groups [1] All groups
Method [2] Wilcoxon rank sum (Van Elteren's test)
P Value [3] 0.0337
Hodges-Lehmann est of diff in medians [4] 0.04
95% Confidence Interval ( 0 to 0.09 )
[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 to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
Measure Description The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 – 10 cm) line representing the patient’s degree of general pain. The two extremities of the line were taken to represent ‘no pain’ and ‘unbearable pain’, respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).
Time Frame Baseline and Week 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.
FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12  
[units: mm]
Least Squares Mean ± Standard Error
  -3  ± 1.8     -3.5  ± 1.9  


Statistical Analysis 1 for Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.8471
Mean Difference (Net) [4] -0.5
95% Confidence Interval ( -5.6 to 4.6 )
[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.



13.  Secondary:   Change From Baseline in the UPDRS Part I Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the UPDRS Part I Total Score at Week 12
Measure Description The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.
Time Frame Baseline and Week 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.
FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  148     139  
Change From Baseline in the UPDRS Part I Total Score at Week 12  
[units: units on a scale]
Median ( Inter-Quartile Range )
  -1.0  
  ( -1.0 to 0.0 )  
  -1.0  
  ( -2.0 to 0.0 )  


Statistical Analysis 1 for Change From Baseline in the UPDRS Part I Total Score at Week 12
Groups [1] All groups
Method [2] Wilcoxon rank sum (Van Elteren's test)
P Value [3] 0.1410
Hodges−Lehmann est of diff in medians [4] 0.0
95% Confidence Interval ( 0.0 to 0.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  N’s exclude patients from the analysis set with incomplete data
[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:
  95% Confidence interval is Distribution−free Confidence Interval (Moses).



14.  Secondary:   Change From Baseline in the UPDRS Part IV Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Change From Baseline in the UPDRS Part IV Total Score at Week 12
Measure Description The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.
Time Frame Baseline and Week 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.
FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data.

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  137     131  
Change From Baseline in the UPDRS Part IV Total Score at Week 12  
[units: score]
Least Squares Mean ± Standard Error
  -0.2  ± 0.1     -0.3  ± 0.1  


Statistical Analysis 1 for Change From Baseline in the UPDRS Part IV Total Score at Week 12
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.5231
Mean Difference (Net) [4] -0.1
Standard Error of the mean ± 0.2
95% Confidence Interval ( -0.5 to 0.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  N’s exclude patients from the analysis set with incomplete data
[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:   Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs   [ Time Frame: Baseline and Week 12 ]

Measure Type Secondary
Measure Title Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Measure Description No text entered.
Time Frame Baseline and Week 12  
Safety Issue Yes  

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
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Measured Values
    Placebo     Pramipexole  
Number of Participants Analyzed  
[units: participants]
  152     144  
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs  
[units: participants]
   
Hypotension     1     1  
Orthostatic hypotension     1     0  

No statistical analysis provided for Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs




  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Pharmaceuticals
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: NCT00297778     History of Changes
Other Study ID Numbers: 248.596, Eudract 2005-003788-22
Study First Received: February 28, 2006
Results First Received: May 22, 2009
Last Updated: March 6, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Finland: Finnish Medicines Agency
France: Afssaps
Germany: Ethikkommission bei der Landesaerztekammer Baden-Wuerttemberg
Italy: Comitato Etico Ospedale Civile S. Spirito, Università "G. D'Annunzio"
Netherlands: Medish Etische toetsingscommissie Atrium MC
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
South Africa: Medicines Council Country
Spain: Unidad de Registro y Tasas, Agencia Espanola del medicamento y productos sanitarios
Sweden: Medical Products Agency
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)