Parkinson Disease
Conditions
Brief summary
The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy. i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*\*PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.
Exclusion criteria
* PD patients with the past history of suicidal attempt, suicidal ideation or tendency * PD patients with suicidal ideation * PD patients with the past history of suicidal tendency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events | for 12 weeks | The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | Baseline and after 12 weeks (or at the time of discontinuation) | Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement. |
| Clinical Global Impression of Improvement | for 12 weeks after initiation of the treatment | Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). |
| Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score | Baseline and after 12 weeks (or at the time of discontinuation) | The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement. |
| Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score | Baseline and after 12 weeks (or at the time of discontinuation) | Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement. |
| Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale | After 12 weeks or at the time of discontinuation | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement. |
Countries
Japan
Participant flow
Recruitment details
The number of patients enrolled was 1089. The number of case reports collected from the patients enrolled in this survey was 1071. Moreover the number of patients analyzed as safety analysis was 1044, because 27 patients were excluded due to protocol violations.
Participants by arm
| Arm | Count |
|---|---|
| BI-Sifrol Tablets According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg. | 1,044 |
| Total | 1,044 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 106 |
| Overall Study | Death | 3 |
| Overall Study | Irregularly enrolled patients | 23 |
| Overall Study | Lack of Efficacy | 14 |
| Overall Study | Lost to Follow-up | 55 |
| Overall Study | No data were collected. | 18 |
| Overall Study | No treatment | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | BI-Sifrol Tablets |
|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 668 Participants |
| Sex: Female, Male Male | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 71 / 1,044 |
| serious Total, serious adverse events | 26 / 1,044 |
Outcome results
Primary
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.
Time frame: for 12 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI-Sifrol Tablets | Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events | Proportion of Adverse Events | 21.7 percentage of participants |
| BI-Sifrol Tablets | Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events | Proportion of Adverse Drug Reactions | 19.2 percentage of participants |
| BI-Sifrol Tablets | Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events | Proportion of Serious Adverse Events | 2.5 percentage of participants |
Secondary
Clinical Global Impression of Improvement
Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Time frame: for 12 weeks after initiation of the treatment
Population: Efficacy analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI-Sifrol Tablets | Clinical Global Impression of Improvement | Unassessable | 24 participants |
| BI-Sifrol Tablets | Clinical Global Impression of Improvement | Very much improved | 76 participants |
| BI-Sifrol Tablets | Clinical Global Impression of Improvement | Much improved | 399 participants |
| BI-Sifrol Tablets | Clinical Global Impression of Improvement | Minimally improved | 348 participants |
| BI-Sifrol Tablets | Clinical Global Impression of Improvement | No effect | 102 participants |
Secondary
Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.
Time frame: Baseline and after 12 weeks (or at the time of discontinuation)
Population: Efficacy analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BI-Sifrol Tablets | Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score | -4.8 Unit on a scale | Standard Deviation 7.8 |
p-value: <0.0001Paired t-test
Secondary
Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.
Time frame: After 12 weeks or at the time of discontinuation
Population: Efficacy Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BI-Sifrol Tablets | Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale | -0.3 units on a scale | Standard Deviation 0.6 |
p-value: <0.0001paired t-test
Secondary
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.
Time frame: Baseline and after 12 weeks (or at the time of discontinuation)
Population: Efficacy analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BI-Sifrol Tablets | Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | -7.2 Unit on a scale | Standard Deviation 9 |
p-value: <0.0001Paired t-test
Secondary
Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.
Time frame: Baseline and after 12 weeks (or at the time of discontinuation)
Population: Efficacy analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BI-Sifrol Tablets | Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score | -0.7 Unit on a scale | Standard Deviation 0.9 |
p-value: <0.0001paired t-test