Parkinson Disease
Conditions
Brief summary
Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.
Interventions
DRUGMirapex LA
Pramipexole Hydrochloride Hydrate
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Adverse Drug Reactions | From baseline up to week 52 | Percentage of subjects with adverse drug reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Effect | Week 52 | Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect. |
| Change From Baseline in Total Score of the UPDRS Part III to Last Observation | Baseline and week 52 | Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score. UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status. The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities. The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia. |
| Change From Baseline in the Modified Hoehn & Yahr to Last Observation | Baseline and week 52 | Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement. |
| Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Week 52 | Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off. |
| Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | Week 52 | Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication. |
Countries
Japan
Participant flow
Recruitment details
This is an Observational study. Patients in the study have received only the standard treatment and no investigational drug was adminstered.
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Parkinson's Disease (PD) Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg. | 569 |
| Total | 569 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 73 |
| Overall Study | Case report form not collected | 25 |
| Overall Study | Improvement | 5 |
| Overall Study | Lack of Efficacy | 24 |
| Overall Study | Lost to follow-up (Changing hospital) | 19 |
| Overall Study | Lost to follow-up (relocation) | 1 |
| Overall Study | Lost to follow-up (Unknown reason) | 10 |
| Overall Study | No visit since the first visit | 16 |
| Overall Study | Other than stated above | 7 |
Baseline characteristics
| Characteristic | Subjects With Parkinson's Disease (PD) |
|---|---|
| Age, Continuous | 68.87 years STANDARD_DEVIATION 9.35 |
| Sex: Female, Male Female | 341 Participants |
| Sex: Female, Male Male | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 569 |
| serious Total, serious adverse events | 30 / 569 |
Outcome results
Primary
Percentage of Adverse Drug Reactions
Percentage of subjects with adverse drug reactions
Time frame: From baseline up to week 52
Population: Safety set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With Parkinson's Disease (PD) | Percentage of Adverse Drug Reactions | 24.78 percentage of participants |
Secondary
Change From Baseline in the Modified Hoehn & Yahr to Last Observation
Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.
Time frame: Baseline and week 52
Population: Efficacy set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With Parkinson's Disease (PD) | Change From Baseline in the Modified Hoehn & Yahr to Last Observation | -0.12 Units on a scale | Standard Deviation 0.4 |
Secondary
Change From Baseline in Total Score of the UPDRS Part III to Last Observation
Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score. UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status. The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities. The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia.
Time frame: Baseline and week 52
Population: Efficacy set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With Parkinson's Disease (PD) | Change From Baseline in Total Score of the UPDRS Part III to Last Observation | -3.73 units on a scale | Standard Deviation 8.27 |
Secondary
Clinical Global Impression of Effect
Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.
Time frame: Week 52
Population: Efficacy set: included all patients in the safety set except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Parkinson's Disease (PD) | Clinical Global Impression of Effect | Very much improved | 14 participants |
| Subjects With Parkinson's Disease (PD) | Clinical Global Impression of Effect | Much improved | 223 participants |
| Subjects With Parkinson's Disease (PD) | Clinical Global Impression of Effect | Minimally improved | 205 participants |
| Subjects With Parkinson's Disease (PD) | Clinical Global Impression of Effect | No effect | 67 participants |
Secondary
Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off.
Time frame: Week 52
Population: Patients in safety set and with concomitant L-DOPA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Parkinson's Disease (PD) | Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Yes | 43 participants |
| Subjects With Parkinson's Disease (PD) | Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | No | 262 participants |
| Subjects With Parkinson's Disease (PD) | Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Unknown | 2 participants |
Secondary
Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.
Time frame: Week 52
Population: Patients in safety set and with concomitant L-DOPA
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Parkinson's Disease (PD) | Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | Yes | 144 participants |
| Subjects With Parkinson's Disease (PD) | Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | No | 163 participants |