Parkinson Disease
Conditions
Brief summary
The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with Parkinson's disease
Exclusion criteria
Patients should have been treated according to the Japanese insert slip
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | during 18 months | The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Improvement | 18 months | Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | Baseline and at 18 months (or at the time of discontinuation) | Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement. |
| Change From Baseline in Modified Hoehn & Yahr Rating Scale | Baseline and at 18 months (or at the time of discontinuation) | A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pramipexole Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day). | 1,553 |
| Total | 1,553 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 274 |
| Overall Study | Death | 20 |
| Overall Study | Irregularly enrolled patients | 10 |
| Overall Study | Lack of Efficacy | 59 |
| Overall Study | Lost to Follow-up | 187 |
| Overall Study | No data was collected. | 65 |
| Overall Study | No treatment | 2 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Pramipexole |
|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 890 Participants |
| Sex: Female, Male Male | 663 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 267 / 1,553 |
| serious Total, serious adverse events | 111 / 1,553 |
Outcome results
Primary
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.
Time frame: during 18 months
Population: Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Proportion of Adverse Drug Reactions | 34.5 percentage of participants |
| Pramipexole | Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Proportion of Serious Adverse Events | 7.2 percentage of participants |
| Pramipexole | Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Proportion of Adverse Events | 42.4 percentage of participants |
Secondary
Change From Baseline in Modified Hoehn & Yahr Rating Scale
A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).
Time frame: Baseline and at 18 months (or at the time of discontinuation)
Population: The number of patients from the efficacy analysis set (1527) who had the assessment of Modified Hoehn \& Yahr rating scale at baseline and at or after 18 months of treatment or at the time of discontinuation (1430).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Change From Baseline in Modified Hoehn & Yahr Rating Scale | -0.2 Unit on a scale | Standard Deviation 0.6 |
Secondary
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Time frame: Baseline and at 18 months (or at the time of discontinuation)
Population: The number of patients from the efficacy analysis set (1527) who had the assessment of UPDRS Part III total score at baseline and at or after 18 months of treatment or at the time of discontinuation (1356).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | -5.4 Unit on a scale | Standard Deviation 10.7 |
Secondary
Clinical Global Impression of Improvement
Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Time frame: 18 months
Population: A total of 26 patients were excluded from 1553 patients (Administration to patients who did not suffer from PD: 20, No efficacy data available: 6). As a result, 1527 patients included to the efficacy analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Clinical Global Impression of Improvement | No effect | 209 Participants |
| Pramipexole | Clinical Global Impression of Improvement | Unassessable | 225 Participants |
| Pramipexole | Clinical Global Impression of Improvement | Minimally improved | 484 Participants |
| Pramipexole | Clinical Global Impression of Improvement | Very much improved | 48 Participants |
| Pramipexole | Clinical Global Impression of Improvement | Much improved | 561 Participants |