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: June 3, 2014
Last verified: April 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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo 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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo 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
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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 ]

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

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 ]

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

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 ]

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

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

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

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

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:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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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 ]

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 ]

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 ]

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

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

15.  Secondary:   Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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