Parkinson Disease
Conditions
Brief summary
The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the 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 who do not receive L-Dopa supplementation
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 36 months | The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Improvement | after 36 months treatment | 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 36 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 36 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 The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations. | 346 |
| Total | 346 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 49 |
| Overall Study | Death | 6 |
| Overall Study | Irregularly enrolled patients | 12 |
| Overall Study | Lack of Efficacy | 13 |
| Overall Study | Lost to Follow-up | 88 |
| Overall Study | No data was collected | 53 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Pramipexole |
|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 187 Participants |
| Sex: Female, Male Male | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 106 / 346 |
| serious Total, serious adverse events | 29 / 346 |
Outcome results
Primary
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
Time frame: during 36 months
Population: 364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 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 Events | 51.7 Proportion (percentage of participants) |
| Pramipexole | Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Proportion of Adverse Drug Reactions | 41.3 Proportion (percentage of participants) |
| Pramipexole | Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Proportion of Serious Adverse Events | 8.4 Proportion (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 36 months (or at the time of discontinuation)
Population: The number of patients (295) means a population who have the assessment of Modified Hoehn \& Yahr rating scale at baseline and at least one post-visit after administration of pramipexole.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Change From Baseline in Modified Hoehn & Yahr Rating Scale | -0.1 Unit on a scale | Standard Deviation 0.7 |
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 36 months (or at the time of discontinuation)
Population: The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | -5.2 Unit on a scale | Standard Deviation 11.2 |
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: after 36 months treatment
Population: There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn't suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Clinical Global Impression of Improvement | Very much improved | 19 Participants |
| Pramipexole | Clinical Global Impression of Improvement | Much improved | 137 Participants |
| Pramipexole | Clinical Global Impression of Improvement | Minimally improved | 97 Participants |
| Pramipexole | Clinical Global Impression of Improvement | No effect | 15 Participants |
| Pramipexole | Clinical Global Impression of Improvement | Unassessable | 71 Participants |