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The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole immediate release | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
| Change From Baseline in UPDRS Part III (Motor Examination) | 14 components rating scale with 27 items scored by 0 (none) - 4 (severe) |
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Inclusion Criteria:
Exclusion Criteria:
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PD patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Amstetten | Austria | ||||
| Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early (PD) | Early Parkinson's Disease (PD) patients |
| FG001 | Advanced PD | Advanced Parkinson's Disease (PD) patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
| Bad Hall |
| Austria |
| Boehringer Ingelheim Investigational Site | Bad Ischl | Austria |
| Boehringer Ingelheim Investigational Site | Bad Radkersburg | Austria |
| Boehringer Ingelheim Investigational Site | Baden | Austria |
| Boehringer Ingelheim Investigational Site | Bregenz | Austria |
| Boehringer Ingelheim Investigational Site | Bruck an der Mur | Austria |
| Boehringer Ingelheim Investigational Site | Deutschlandsberg | Austria |
| Boehringer Ingelheim Investigational Site | Dornbirn | Austria |
| Boehringer Ingelheim Investigational Site | Eisenstadt | Austria |
| Boehringer Ingelheim Investigational Site | Feldkirch | Austria |
| Boehringer Ingelheim Investigational Site | Feldkirchen in Kärnten | Austria |
| Boehringer Ingelheim Investigational Site | Gänserndorf | Austria |
| Boehringer Ingelheim Investigational Site | Gmunden | Austria |
| Boehringer Ingelheim Investigational Site | Graz | Austria |
| Boehringer Ingelheim Investigational Site | Grieskirchen | Austria |
| Boehringer Ingelheim Investigational Site | Hall in Tirol | Austria |
| Boehringer Ingelheim Investigational Site | Hallein | Austria |
| Boehringer Ingelheim Investigational Site | Hermagor | Austria |
| Boehringer Ingelheim Investigational Site | Hohenems | Austria |
| Boehringer Ingelheim Investigational Site | Hollabrunn | Austria |
| Boehringer Ingelheim Investigational Site | Horn | Austria |
| Boehringer Ingelheim Investigational Site | Imst | Austria |
| Boehringer Ingelheim Investigational Site | Innsbruck | Austria |
| Boehringer Ingelheim Investigational Site | Judenburg | Austria |
| Boehringer Ingelheim Investigational Site | Kapfenberg | Austria |
| Boehringer Ingelheim Investigational Site | Klagenfurt | Austria |
| Boehringer Ingelheim Investigational Site | Klosterneuburg | Austria |
| Boehringer Ingelheim Investigational Site | Knittelfeld | Austria |
| Boehringer Ingelheim Investigational Site | Krems | Austria |
| Boehringer Ingelheim Investigational Site | Kufstein | Austria |
| Boehringer Ingelheim Investigational Site | Leoben | Austria |
| Boehringer Ingelheim Investigational Site | Lienz | Austria |
| Boehringer Ingelheim Investigational Site | Lilienfeld | Austria |
| Boehringer Ingelheim Investigational Site | Linz | Austria |
| Boehringer Ingelheim Investigational Site | Melk | Austria |
| Boehringer Ingelheim Investigational Site | Neunkirchen | Austria |
| Boehringer Ingelheim Investigational Site | Oberwart | Austria |
| Boehringer Ingelheim Investigational Site | Ried im Innkreis | Austria |
| Boehringer Ingelheim Investigational Site | Salzburg | Austria |
| Boehringer Ingelheim Investigational Site | Sankt Pölten | Austria |
| Boehringer Ingelheim Investigational Site | Sankt Veit an der Glan | Austria |
| Boehringer Ingelheim Investigational Site | Scheibbs | Austria |
| Boehringer Ingelheim Investigational Site | Schwechat | Austria |
| Boehringer Ingelheim Investigational Site | Spital An Der Drau | Austria |
| Boehringer Ingelheim Investigational Site | St Johann im Pongau | Austria |
| Boehringer Ingelheim Investigational Site | Stegersbach | Austria |
| Boehringer Ingelheim Investigational Site | Stockerau | Austria |
| Boehringer Ingelheim Investigational Site | Telfs | Austria |
| Boehringer Ingelheim Investigational Site | Traun | Austria |
| Boehringer Ingelheim Investigational Site | Vienna | Austria |
| Boehringer Ingelheim Investigational Site | Villach | Austria |
| Boehringer Ingelheim Investigational Site | Vöcklabruck | Austria |
| Boehringer Ingelheim Investigational Site | W. Neustadt | Austria |
| Boehringer Ingelheim Investigational Site | Wels | Austria |
| Boehringer Ingelheim Investigational Site | Wolfsberg | Austria |
| Boehringer Ingelheim Investigational Site | Wörgl | Austria |
| COMPLETED |
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| NOT COMPLETED |
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Safety set (SAF)
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| ID | Title | Description |
|---|---|---|
| BG000 | Early PD | Early Parkinson's Disease (PD) patients |
| BG001 | Advanced PD | Advanced Parkinson's Disease (PD) patients |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline data are presented for the safety analysis set (including data of all 286 patients - 189 early PD patients / 97 advanced PD patients - reported to have received at least one dose of study drug, i.e. pramipexole). For Age, Continuous the number of patients with age information collected was 187 for Early PD and 94 for Advanced PD. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex/Gender, Customized | Baseline data are presented for the safety analysis set (including data of all 286 patients - 189 early PD patients / 97 advanced PD patients - reported to have received at least one dose of study drug, i.e. pramipexole). For two patients the participating physicians did not enter the gender in the CRF, therefore, they were listed as "missing" | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score | Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis | Posted | Median | Inter-Quartile Range | Points on a scale | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
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| Primary | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. | Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis | Posted | Median | Inter-Quartile Range | Points on a scale | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
|
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| Primary | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. | Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis | Posted | Median | Inter-Quartile Range | Points on a scale | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
|
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| Primary | Change From Baseline in UPDRS Part III (Motor Examination) | 14 components rating scale with 27 items scored by 0 (none) - 4 (severe) | Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis | Posted | Median | Inter-Quartile Range | Points on a scale | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) |
|
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Up to 16 weeks
The safety analysis set (SAF) includes the data of all 286 patients (189 early PD patients/ 97 advanced PD patients - reported to have received at least one dose of study drug, i.e. pramipexole
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early PD | Early Parkinson's Disease (PD) patients | 0 | 189 | 0 | 189 | ||
| EG001 | Advanced PD | Advanced Parkinson's Disease (PD) patients | 1 | 97 | 0 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| missing |
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