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Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

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ClinicalTrials.gov Identifier: NCT01100073
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : September 20, 2010
Last Update Posted : April 11, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Parkinson Disease
Enrollment 1703
Recruitment Details  
Pre-assignment Details
  • enrolled in study: 1703
  • treated (received Mirapexin): 1699 (i.e. 4 patients no record of receiving treatment)
  • completed study: 1599 (i.e. 100 discontinued prematurely)
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Period Title: Overall Study
Started 1699 [1]
Completed 1599 [2]
Not Completed 100
Reason Not Completed
Lack of Efficacy             4
Insufficient Tolerability             21
Withdrawal by Subject             13
Lost to Follow-up             39
Lack of effect + patient's wish             2
Insufficient tolerability +patients wish             8
Other             8
Missing             5
[1]
Baseline (Visit 1)
[2]
End of study (Visit 3)
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Baseline Participants 1699
Hide Baseline Analysis Population Description
Treated set (TS) (31 patients were missing age and 17 patients were missing gender)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1699 participants
66.4  (9.70)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1699 participants
Female 844
Male 838
Category title missing 17
1.Primary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
Hide Description Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Time Frame Week 0 to weeks 9-16 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1424
Mean (Standard Deviation)
Unit of Measure: Points on UPDRS scale
5.20  (4.5)
2.Primary Outcome
Title Change From Baseline in UPDRS Part III Score at the End of Maintenance
Hide Description Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Time Frame Week 0 to weeks 9-16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1094
Mean (Standard Deviation)
Unit of Measure: Points on UPDRS scale
12  (9.9)
3.Primary Outcome
Title Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
Hide Description Change (reduction) in tremor amplitude from baseline to end of study for the right hand
Time Frame Week 0 to weeks 9-16 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 949
Mean (Standard Deviation)
Unit of Measure: millimeters of tremor amplitude
0.3  (1.6)
4.Primary Outcome
Title Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
Hide Description Change (reduction) in tremor amplitude from baseline to end of study for the left hand
Time Frame Week 0 to weeks 9-16 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 962
Mean (Standard Deviation)
Unit of Measure: millimeters of tremor amplitude
0.2  (1.7)
5.Primary Outcome
Title Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
Hide Description Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
Time Frame Week 0 to weeks 9-16 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS tremor score (UPDRS items 16, 20, 21) available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1169
Mean (Standard Deviation)
Unit of Measure: Points on UPDRS scale
4.1  (3.4)
6.Primary Outcome
Title Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
Hide Description Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)
Time Frame Week 0 to weeks 9-16 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - Patients for whom baseline and end of study PDQ-39 score available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1239
Mean (Standard Deviation)
Unit of Measure: unit on a scale
15  (18.4)
7.Secondary Outcome
Title Final Dose Distribution
Hide Description Final Mirapexin® dose distribution at the end of study
Time Frame Enter Week 0 to weeks 9-16 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Total patients. Number of participants analysed differs for each outcome measure because not all evaluations were performed / documented on every patient.
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1623
Median (Full Range)
Unit of Measure: milligrams of Mirapexin® (salt)
3.0
(0.25 to 7.5)
8.Secondary Outcome
Title Change From Baseline in UPDRS Part II Score at the End of Up-titration
Hide Description Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Time Frame Enter Week 0 to weeks 1-8 (Visit 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients for whom baseline and Visit 2 UPDRS Part II scores available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1490
Mean (Standard Deviation)
Unit of Measure: Points on a UPDRS scale
3.1  (3.5)
9.Secondary Outcome
Title Change From Baseline in UPDRS Part III Score at the End of Up-titration
Hide Description Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Time Frame Enter Week 0 to weeks 1-8 (Visit 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients for whom baseline and Visit 2 UPDRS Part III scores available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1131
Mean (Standard Deviation)
Unit of Measure: Points on a UPDRS scale
7.6  (8.1)
10.Secondary Outcome
Title Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration
Hide Description Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
Time Frame Enter Week 0 to weeks 1-8 (Visit 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients for whom baseline and Visit 2 UPDRS Part II and III scores available
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1207
Mean (Standard Deviation)
Unit of Measure: Points on a UPDRS scale
2.5  (2.9)
11.Secondary Outcome
Title Incidence, Relationship and Seriousness of Adverse Events
Hide Description Total number of adverse events (AEs), causality and level of seriousness
Time Frame Week 0 to weeks 9-16 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Total patients
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1699
Measure Type: Number
Unit of Measure: Number of events
Incidence (Total number of AEs) 266
Related (Number of treatment related AEs) 230
SAE (Number of serious adverse events) 3
12.Secondary Outcome
Title Number of Premature Discontinuations
Hide Description Number of patients discontinuing the study prematurely
Time Frame Week 0 to weeks 9-16 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Total patients
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
Overall Number of Participants Analyzed 1699
Measure Type: Number
Unit of Measure: Participants
100
Time Frame Up to 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
All-Cause Mortality
Mirapexin® (Pramipexole)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mirapexin® (Pramipexole)
Affected / at Risk (%) # Events
Total   3/1699 (0.18%)    
Cardiac disorders   
Myocardial Infarction  1  1/1699 (0.06%)  1
Musculoskeletal and connective tissue disorders   
Vertebral Fracture  1  1/1699 (0.06%)  1
Nervous system disorders   
Acute Stroke  1  1/1699 (0.06%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mirapexin® (Pramipexole)
Affected / at Risk (%) # Events
Total   0/1699 (0.00%)    
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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01100073     History of Changes
Other Study ID Numbers: 248.657
First Submitted: March 18, 2010
First Posted: April 8, 2010
Results First Submitted: July 30, 2010
Results First Posted: September 20, 2010
Last Update Posted: April 11, 2014