Parkinson Disease
Conditions
Brief summary
This is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. Parkinson disease patients with different severity who have already used pramipexole could be observed in this study. In the whole observation period, treatment decision was determined by physician and patient completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient withdraw, laboratory test.
Detailed description
Purpose:
Interventions
DRUGpramipexole
as prescibed by the investigator
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria 2. Age: from 30 to 75 years old 3. Stage I-IV of revised Hoehn-Yahr standards 4. With current use of pramipexole 5. Informed consent signed by every subject
Exclusion criteria
1. Diagnosis of Parkinson¿s syndrome 2. Current use of psychotolytic medications 3. Allergic to pramipexole or any other ingredient of pramipexole 4. Female patients in pregnancy and lactation 5. Patients who were participating in other clinical studies by signing relevant informed consent or who received other investigational drugs within 30 days prior to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AE/SAE | 12 weeks | The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Baseline (Visit 1) and 12 weeks (Visit 3) | Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor). |
| The Dosage Related Information of Pramipexole at Baseline | baseline | At enrollment, the distribution of patients in 3 pramipexole dosage categories. |
| The Dosage Related Information of Pramipexole at the End of Study | 12 weeks | At the end of study, the distribution of patients in 3 pramipexole dosage categories. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pramipexole Goup | 2,017 |
| Total | 2,017 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 116 |
Baseline characteristics
| Characteristic | Pramipexole Goup |
|---|---|
| Age, Continuous | 62.09 years STANDARD_DEVIATION 9.67 |
| Course of Parkinson's disease | 3 years INTER_QUARTILE_RANGE 2.5 |
| Gender Female | 840 Number of participants |
| Gender Male | 1174 Number of participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,017 |
| serious Total, serious adverse events | 0 / 2,017 |
Outcome results
Primary
Incidence of AE/SAE
The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.
Time frame: 12 weeks
Population: There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole Goup | Incidence of AE/SAE | 5.16 Percentage of participants |
Secondary
Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)
Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).
Time frame: Baseline (Visit 1) and 12 weeks (Visit 3)
Population: There were 1891 patients in full analysis set(FAS). FAS includes all patients who fulfilled the inclusion criteria and exclusion criteria, without missing PGI values at visit 1 and visit 3. In the recruited 2017 patients, 116 patients didn't fully meet the inclusion or exclusion criteria and 10 patients missed PGI data at visit 1 or visit 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pramipexole Goup | Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Visit 1 | 3.53 unit on a scale | Standard Deviation 1.23 |
| Pramipexole Goup | Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Visit 3 | 2.48 unit on a scale | Standard Deviation 0.69 |
Secondary
The Dosage Related Information of Pramipexole at Baseline
At enrollment, the distribution of patients in 3 pramipexole dosage categories.
Time frame: baseline
Population: There were 2017 patients in SAS set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole Goup | The Dosage Related Information of Pramipexole at Baseline | dosage < 0.75mg/d | 84.93 percentage of patients |
| Pramipexole Goup | The Dosage Related Information of Pramipexole at Baseline | 1.5mg/d > dosage ≥ 0.75mg/d | 12.99 percentage of patients |
| Pramipexole Goup | The Dosage Related Information of Pramipexole at Baseline | dosage ≥ 1.5mg/d | 2.08 percentage of patients |
Secondary
The Dosage Related Information of Pramipexole at the End of Study
At the end of study, the distribution of patients in 3 pramipexole dosage categories.
Time frame: 12 weeks
Population: There were 2017 patients in SAS set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole Goup | The Dosage Related Information of Pramipexole at the End of Study | dosage < 0.75mg/d | 33.56 percentage of patients |
| Pramipexole Goup | The Dosage Related Information of Pramipexole at the End of Study | 1.5mg/d > dosage ≥ 0.75mg/d | 46.16 percentage of patients |
| Pramipexole Goup | The Dosage Related Information of Pramipexole at the End of Study | dosage ≥ 1.5mg/d | 20.28 percentage of patients |