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

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ClinicalTrials.gov Identifier: NCT00297778
Recruitment Status : Completed
First Posted : March 1, 2006
Results First Posted : September 24, 2009
Last Update Posted : June 9, 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
Conditions Parkinson Disease
Depression
Interventions Drug: Pramipexole
Other: Placebo
Enrollment 296
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description Placebo tablet matching active treatment 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.
Period Title: Overall Study
Started 152 144
Completed 133 124
Not Completed 19 20
Reason Not Completed
Adverse Event             16             10
Withdrawal by Subject             1             5
Lack of Efficacy             2             1
Non-compliant with trial protocol             0             3
Other             0             1
Arm/Group Title Placebo Pramipexole Total
Hide Arm/Group Description Placebo tablet matching active treatment 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 of all reporting groups
Overall Number of Baseline Participants 152 144 296
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 144 participants 296 participants
66.6  (9.9) 67.4  (9.0) 67  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 296 participants
Female
74
  48.7%
82
  56.9%
156
  52.7%
Male
78
  51.3%
62
  43.1%
140
  47.3%
1.Primary Outcome
Title Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
-4  (0.5) -5.9  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval 95%
-3.4 to -0.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
Hide Description BDI clinical response was defined as a reduction of ≥50% from baseline
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score).
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 147 139
Measure Type: Number
Unit of Measure: participants
27 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0535
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.758
Confidence Interval 95%
0.992 to 3.115
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.7  (0.3) -2.5  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0346
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8
Confidence Interval 95%
-1.5 to -0.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(-2 to 0)
0
(-2 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5244
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval 95%
-1 to 0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-1
(-1 to 0)
-1
(-2 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments [Not Specified]
Method van Elteren (country stratification)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0
Confidence Interval 95%
0 to 0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the UPDRS Part II Total Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.2  (0.3) -2.4  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2
Confidence Interval 95%
-1.9 to -0.4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the UPDRS Part III Total Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 138
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.2  (0.5) -4.4  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.2
Confidence Interval 95%
-3.7 to -0.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the UPDRS Part II+III Total Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 138
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.4  (0.7) -6.8  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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 -3.4
Confidence Interval 95%
-5.4 to -1.5
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
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)
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Median (Full Range)
Unit of Measure: units on a scale
3
(1 to 6)
3
(1 to 6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.821
Confidence Interval 95%
1.187 to 2.794
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 127 108
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-2.4
(-8.9 to 2.6)
-3.3
(-8.9 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1925
Comments [Not Specified]
Method van Elteren (country stratification)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.3
Confidence Interval 95%
-3.3 to 0.8
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 144 136
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(-0.06 to 0.12)
0.07
(0 to 0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0337
Comments [Not Specified]
Method Wilcoxon rank sum (Van Elteren's test)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann est of diff in medians
Estimated Value 0.04
Confidence Interval 95%
0 to 0.09
Estimation Comments [Not Specified]
12.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Least Squares Mean (Standard Error)
Unit of Measure: mm
-3  (1.8) -3.5  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8471
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval 95%
-5.6 to 4.6
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in the UPDRS Part I Total Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 148 139
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-1.0
(-1.0 to 0.0)
-1.0
(-2.0 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments N’s exclude patients from the analysis set with incomplete data
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1410
Comments [Not Specified]
Method Wilcoxon rank sum (Van Elteren's test)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges−Lehmann est of diff in medians
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.0 to 0.0
Estimation Comments 95% Confidence interval is Distribution−free Confidence Interval (Moses).
14.Secondary Outcome
Title Change From Baseline in the UPDRS Part IV Total Score at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data.
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 137 131
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.1) -0.3  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pramipexole
Comments N’s exclude patients from the analysis set with incomplete data
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5231
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description:
Placebo tablet matching active treatment
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.
Overall Number of Participants Analyzed 152 144
Measure Type: Number
Unit of Measure: participants
Hypotension 1 1
Orthostatic hypotension 1 0
Time Frame First drug intake up to 48 hours after the last drug intake
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Pramipexole
Hide Arm/Group Description Placebo tablet matching active treatment 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.
All-Cause Mortality
Placebo Pramipexole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pramipexole
Affected / at Risk (%) Affected / at Risk (%)
Total   6   6 
Cardiac disorders     
Angina unstable  1  1/152 (0.66%)  0/144 (0.00%) 
Cardiac failure  1  1/152 (0.66%)  1/144 (0.69%) 
Gastrointestinal disorders     
Abdominal pain  1  1/152 (0.66%)  0/144 (0.00%) 
Gastroduodenal ulcer  1  1/152 (0.66%)  0/144 (0.00%) 
Volvulus  1  1/152 (0.66%)  0/144 (0.00%) 
Infections and infestations     
Endocarditis  1  0/152 (0.00%)  1/144 (0.69%) 
Injury, poisoning and procedural complications     
Accident at home  1  1/152 (0.66%)  0/144 (0.00%) 
Comminuted fracture  1  1/152 (0.66%)  0/144 (0.00%) 
Fall  1  1/152 (0.66%)  1/144 (0.69%) 
Femoral neck fracture  1  0/152 (0.00%)  1/144 (0.69%) 
Skull fracture base  1  1/152 (0.66%)  0/144 (0.00%) 
Traumatic brain injury  1  1/152 (0.66%)  0/144 (0.00%) 
Metabolism and nutrition disorders     
Hyperlipidaemia  1  0/152 (0.00%)  1/144 (0.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/152 (0.00%)  1/144 (0.69%) 
Spinal osteoarthritis  1  1/152 (0.66%)  0/144 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  1  0/152 (0.00%)  1/144 (0.69%) 
Cerebrovascular accident  1  0/152 (0.00%)  1/144 (0.69%) 
Parkinson disease  1  1/152 (0.66%)  0/144 (0.00%) 
Radicular pain  1  1/152 (0.66%)  0/144 (0.00%) 
Syncope  1  0/152 (0.00%)  1/144 (0.69%) 
Psychiatric disorders     
Hallucination  1  0/152 (0.00%)  1/144 (0.69%) 
Renal and urinary disorders     
Anuria  1  0/152 (0.00%)  1/144 (0.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pramipexole
Affected / at Risk (%) Affected / at Risk (%)
Total   58   71 
Ear and labyrinth disorders     
Vertigo  1  4/152 (2.63%)  10/144 (6.94%) 
Gastrointestinal disorders     
Nausea  1  26/152 (17.11%)  24/144 (16.67%) 
General disorders     
Fatigue  1  9/152 (5.92%)  8/144 (5.56%) 
Nervous system disorders     
Dizziness  1  9/152 (5.92%)  16/144 (11.11%) 
Headache  1  12/152 (7.89%)  16/144 (11.11%) 
Somnolence  1  12/152 (7.89%)  15/144 (10.42%) 
Dyskinesia  1  4/152 (2.63%)  10/144 (6.94%) 
Psychiatric disorders     
Insomnia  1  4/152 (2.63%)  8/144 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00297778     History of Changes
Other Study ID Numbers: 248.596
Eudract 2005-003788-22
First Submitted: February 28, 2006
First Posted: March 1, 2006
Results First Submitted: May 22, 2009
Results First Posted: September 24, 2009
Last Update Posted: June 9, 2014