Parkinson's Disease
Conditions
Brief summary
The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.
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
* Early and advanced idiopathic Parkinson's disease * Male and female patients over 18 years of age * Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)
Exclusion criteria
* Ongoing treatment with pramipexole ER *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | From the treatment initiation to the end of study, on average 92.9 days | The number of patients with any adverse events (AEs), patients with drug-related AEs. |
| Proportion of Patients With Withdrawals Due to Adverse Events. | 16 weeks | Patients who discontinued treatment due to adverse events including deaths. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score | Baseline and the end of study (up to 16 weeks) | Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change\>0) in the score means improvement. |
| Clinical Global Impression of Improvement (CGI-I) Responder Rate | Baseline and the end of study (up to 16 weeks) | The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved. |
| Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction | Baseline and the end of study (up to 16 weeks) | The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change\>0) reflects an improvement in patient satisfaction. |
| Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score | Baseline and the end of study (up to 16 weeks) | The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change \>0 reflects an improvement |
Countries
Austria, Estonia, Kazakhstan, Romania, Serbia, Slovakia, Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Patients with Parkinson's disease in routine clinical practice. | 1,814 |
| Total | 1,814 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 32 |
| Overall Study | Death | 2 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Other reason than stated above | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 9.2 |
| Gender Female | 910 participants |
| Gender Male | 889 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,814 |
| serious Total, serious adverse events | 4 / 1,814 |
Outcome results
Primary
Incidence of Adverse Events
The number of patients with any adverse events (AEs), patients with drug-related AEs.
Time frame: From the treatment initiation to the end of study, on average 92.9 days
Population: Patients from the Treated Set (TS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Incidence of Adverse Events | Patients with any AE | 105 participants |
| All Patients | Incidence of Adverse Events | Patients with drug-related AEs | 56 participants |
Primary
Proportion of Patients With Withdrawals Due to Adverse Events.
Patients who discontinued treatment due to adverse events including deaths.
Time frame: 16 weeks
Population: Patients from the Treated Set (TS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Proportion of Patients With Withdrawals Due to Adverse Events. | 0.019 proportion of participants |
Secondary
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score
The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change \>0 reflects an improvement
Time frame: Baseline and the end of study (up to 16 weeks)
Population: Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score | 0.6 units on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score
Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change\>0) in the score means improvement.
Time frame: Baseline and the end of study (up to 16 weeks)
Population: Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Patients | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score | UPDRS Part I score (N=1756) | 1.1 units on a scale | Standard Deviation 1.6 |
| All Patients | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score | UPDRS Part III score (N=1670) | 10.6 units on a scale | Standard Deviation 9.4 |
Secondary
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction
The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change\>0) reflects an improvement in patient satisfaction.
Time frame: Baseline and the end of study (up to 16 weeks)
Population: Patients from FAS with evaluable data in VAS at baseline and at visit 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction | 18.5 units on a scale | Standard Deviation 22.6 |
Secondary
Clinical Global Impression of Improvement (CGI-I) Responder Rate
The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.
Time frame: Baseline and the end of study (up to 16 weeks)
Population: Patients from FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Clinical Global Impression of Improvement (CGI-I) Responder Rate | 84.3 percentage of participants |