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Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic Parkinson's Disease Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sifrol® | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parkinson signs and symptoms by means of a 4-point rating scale | up to 6 weeks | |
| Occurrence of tremor (rest and postural) by means of a 4-point rating scale | Short Parkinson's Evaluation Scale (SPES) | up to 6 weeks |
| Change in severity of kinetic tremor assessed by tremor spiral test | up to 6 weeks | |
| Occurrence of depression by means of a 4-point SPES rating scale | up to 6 weeks | |
| Change in severity of depression by means of an 8-point rating scale | Clinical Global Impression (CGI) rating scale | up to 6 weeks |
| Self-Assessment of depression by patient by means of six different visual analogue scales (VAS) | VAS (10 cm) | up to 6 weeks |
| Assessment of efficacy by investigator on a 5-point rating scale | after 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse drug reactions | up to 6 weeks | |
| Assessment of tolerability by investigator on a 5-point scale | after 6 weeks | |
| Assessment of tolerability by patient on a 5-point scale |
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Inclusion Criteria:
Exclusion Criteria:
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Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®
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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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| after 6 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 |