Parkinson Disease
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Idiopathic Parkinson's disease with or without fluctuations 2. Indication for treatment with pramipexole (Mirapexin®) 3. Presence of at least mild tremor symptoms (as judged by the treating physician)
Exclusion criteria
1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients. 2. Ongoing treatment with pramipexole (Mirapexin®)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance | Week 0 to weeks 9-16 (Visit 3) | 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) |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance | Week 0 to weeks 9-16 (Visit 3) | 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) |
| Change From Baseline in UPDRS Part III Score at the End of Maintenance | Week 0 to weeks 9-16 | 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) |
| Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand) | Week 0 to weeks 9-16 (Visit 3) | Change (reduction) in tremor amplitude from baseline to end of study for the right hand |
| Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand) | Week 0 to weeks 9-16 (Visit 3) | Change (reduction) in tremor amplitude from baseline to end of study for the left hand |
| Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3) | Week 0 to weeks 9-16 (Visit 3) | Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final Dose Distribution | Enter Week 0 to weeks 9-16 (Visit 3) | Final Mirapexin® dose distribution at the end of study |
| Change From Baseline in UPDRS Part II Score at the End of Up-titration | Enter Week 0 to weeks 1-8 (Visit 2) | 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) |
| Change From Baseline in UPDRS Part III Score at the End of Up-titration | Enter Week 0 to weeks 1-8 (Visit 2) | 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) |
| Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration | Enter Week 0 to weeks 1-8 (Visit 2) | 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) |
| Incidence, Relationship and Seriousness of Adverse Events | Week 0 to weeks 9-16 (end of study) | Total number of adverse events (AEs), causality and level of seriousness |
| Number of Premature Discontinuations | Week 0 to weeks 9-16 (end of study) | Number of patients discontinuing the study prematurely |
Countries
Estonia, Latvia, Romania, Russia, Serbia, Slovakia, Slovenia, Ukraine
Participant flow
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)
Participants by arm
| Arm | Count |
|---|---|
| Mirapexin® (Pramipexole) 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. | 1,699 |
| Total | 1,699 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insufficient Tolerability | 21 |
| Overall Study | Insufficient tolerability +patients wish | 8 |
| Overall Study | Lack of effect + patient's wish | 2 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 39 |
| Overall Study | Missing | 5 |
| Overall Study | Other | 8 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Mirapexin® (Pramipexole) |
|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 9.7 |
| Sex/Gender, Customized Category title missing | 17 participants |
| Sex/Gender, Customized Female | 844 participants |
| Sex/Gender, Customized Male | 838 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,699 |
| serious Total, serious adverse events | 3 / 1,699 |
Outcome results
Primary
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)
Population: Full analysis set (FAS) - Patients for whom baseline and end of study PDQ-39 score available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance | 15 unit on a scale | Standard Deviation 18.4 |
Primary
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)
Population: Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand) | 0.2 millimeters of tremor amplitude | Standard Deviation 1.7 |
Primary
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)
Population: Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand) | 0.3 millimeters of tremor amplitude | Standard Deviation 1.6 |
Primary
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)
Population: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS tremor score (UPDRS items 16, 20, 21) available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3) | 4.1 Points on UPDRS scale | Standard Deviation 3.4 |
Primary
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)
Population: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance | 5.20 Points on UPDRS scale | Standard Deviation 4.5 |
Primary
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
Population: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in UPDRS Part III Score at the End of Maintenance | 12 Points on UPDRS scale | Standard Deviation 9.9 |
Secondary
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)
Population: Patients for whom baseline and Visit 2 UPDRS Part III scores available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in UPDRS Part III Score at the End of Up-titration | 7.6 Points on a UPDRS scale | Standard Deviation 8.1 |
Secondary
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)
Population: Patients for whom baseline and Visit 2 UPDRS Part II scores available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in UPDRS Part II Score at the End of Up-titration | 3.1 Points on a UPDRS scale | Standard Deviation 3.5 |
Secondary
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)
Population: Patients for whom baseline and Visit 2 UPDRS Part II and III scores available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration | 2.5 Points on a UPDRS scale | Standard Deviation 2.9 |
Secondary
Final Dose Distribution
Final Mirapexin® dose distribution at the end of study
Time frame: Enter Week 0 to weeks 9-16 (Visit 3)
Population: Total patients. Number of participants analysed differs for each outcome measure because not all evaluations were performed / documented on every patient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mirapexin® (Pramipexole) | Final Dose Distribution | 3.0 milligrams of Mirapexin® (salt) |
Secondary
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)
Population: Total patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Incidence, Relationship and Seriousness of Adverse Events | Incidence (Total number of AEs) | 266 Number of events |
| Mirapexin® (Pramipexole) | Incidence, Relationship and Seriousness of Adverse Events | Related (Number of treatment related AEs) | 230 Number of events |
| Mirapexin® (Pramipexole) | Incidence, Relationship and Seriousness of Adverse Events | SAE (Number of serious adverse events) | 3 Number of events |
Secondary
Number of Premature Discontinuations
Number of patients discontinuing the study prematurely
Time frame: Week 0 to weeks 9-16 (end of study)
Population: Total patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirapexin® (Pramipexole) | Number of Premature Discontinuations | 100 Participants |