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Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cumulative daily doses of Sifrol® | Changes in the doses between visits are evaluated using Wilcoxon's signed rank test | up to 8 weeks |
| Changes in cumulative daily doses of L-dopa | Changes in the doses between visits are evaluated using Wilcoxon's signed rank test | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score | Baseline, after 8 weeks | |
| Change from Baseline in SPES subscales | Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced idiopathic Parkinson's diease recruited at specialist practices and hospitals
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Baseline, after 8 weeks |
| Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score | patients with SPES depression >= 2 | Baseline, after 8 weeks |
| Change from Baseline in Tremor Impact Scale (TIS-D) total score | Baseline, after 8 weeks |
| Change from Baseline in global Parkinson's Disease (PD) symptoms | Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor | Baseline, after 8 weeks |
| Global assessment of efficacy by investigator on a 5-point scale | after 8 weeks |
| Global assessment of tolerability by investigator on a 5-point scale | after 8 weeks |
| Number of patients with adverse events | up to 8 weeks |
| Number of patients with adverse drug reactions | up to 8 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |