The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.
Study Type
OBSERVATIONAL
Enrollment
1,703
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
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)
Change From Baseline in UPDRS Part III Score at the End of Maintenance
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
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
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)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
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)
Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
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)
Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
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)
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Boehringer Ingelheim Investigational Site 5
Keila, Estonia
Boehringer Ingelheim Investigational Site 4
Kohtla-Järve, Estonia
Boehringer Ingelheim Investigational Site 6
Rakvere, Estonia
Boehringer Ingelheim Investigational Site 1
Tallinn, Estonia
Boehringer Ingelheim Investigational Site 2
Tallinn, Estonia
Boehringer Ingelheim Investigational Site 3
Tallinn, Estonia
Boehringer Ingelheim Investigational Site 7
Tartu, Estonia
Boehringer Ingelheim Investigational Site 8
Valga, Estonia
Boehringer Ingelheim Investigational Site 9
Kuldīga, Latvia
Boehringer Ingelheim Investigational Site 12
Liepāja, Latvia
...and 205 more locations
Final Dose Distribution
Final Mirapexin® dose distribution at the end of study
Time frame: Enter Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in UPDRS Part II Score at the End of Up-titration
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)
Change From Baseline in UPDRS Part III Score at the End of Up-titration
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)
Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration
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)
Incidence, Relationship and Seriousness of Adverse Events
Total number of adverse events (AEs), causality and level of seriousness
Time frame: Week 0 to weeks 9-16 (end of study)
Number of Premature Discontinuations
Number of patients discontinuing the study prematurely
Time frame: Week 0 to weeks 9-16 (end of study)