Parkinson Disease
Conditions
Brief summary
In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Parkinson Disease patients presenting to neurologist for first time
Exclusion criteria
\- Hypersensitivity to the active substance or to any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated | 4 - 8 weeks | Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I | Baseline and 4 to 8 weeks | Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability) |
| Change From Baseline in UPDRS Part III | Baseline and 4 - 8 weeks | Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability). |
| Global Clinical Assessments of Efficacy of Mirapexin® for All Patients | 4 - 8 weeks | Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. |
Countries
Croatia, Czechia, Estonia, Hungary, Romania, Russia, Serbia, Slovakia, Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirapexin® (Pramipexole) The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use. | 2,448 |
| Total | 2,448 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insufficient tolerability (IT) | 17 |
| Overall Study | IT and patient wish | 8 |
| Overall Study | Lack of Efficacy | 36 |
| Overall Study | Lack of efficacy and patient wish | 1 |
| Overall Study | Other | 32 |
| Overall Study | Patients wish and other reason | 1 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Mirapexin® (Pramipexole) |
|---|---|
| Age, Continuous | 67.23 years |
| Sex/Gender, Customized Female | 1145 participants |
| Sex/Gender, Customized Male | 1274 participants |
| Sex/Gender, Customized missing | 29 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,448 |
| serious Total, serious adverse events | 0 / 2,448 |
Outcome results
Primary
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated
Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)
Time frame: 4 - 8 weeks
Population: Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated | Very good | 403 Participants |
| Mirapexin® (Pramipexole) | Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated | Good | 323 Participants |
| Mirapexin® (Pramipexole) | Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated | Moderate | 73 Participants |
| Mirapexin® (Pramipexole) | Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated | Poor | 15 Participants |
| Mirapexin® (Pramipexole) | Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated | Global Clinical Assessment (GCA) missing | 19 Participants |
Secondary
Change From Baseline in UPDRS Part III
Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).
Time frame: Baseline and 4 - 8 weeks
Population: Full Analysis set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in UPDRS Part III | -11.18 Unit on a scale |
Secondary
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I
Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)
Time frame: Baseline and 4 to 8 weeks
Population: Full Analysis set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirapexin® (Pramipexole) | Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I | -1.20 Unit on a scale |
Secondary
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients
Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
Time frame: 4 - 8 weeks
Population: Treated set (TS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirapexin® (Pramipexole) | Global Clinical Assessments of Efficacy of Mirapexin® for All Patients | Very good | 1043 Number of Participants |
| Mirapexin® (Pramipexole) | Global Clinical Assessments of Efficacy of Mirapexin® for All Patients | Good | 1004 Number of Participants |
| Mirapexin® (Pramipexole) | Global Clinical Assessments of Efficacy of Mirapexin® for All Patients | Moderate | 263 Number of Participants |
| Mirapexin® (Pramipexole) | Global Clinical Assessments of Efficacy of Mirapexin® for All Patients | Poor | 55 Number of Participants |
| Mirapexin® (Pramipexole) | Global Clinical Assessments of Efficacy of Mirapexin® for All Patients | Global Clinical Assessment (GCA) missing | 83 Number of Participants |