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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000400-81 | EudraCT Number |
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The study was terminated on 31 May, 2011, due to strategic considerations.
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This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.
Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a minimum 1-week screening period, a 4-week switch and stabilization period and an 8-week maintenance period. The second part of the study will be open label pardoprunox treatment with a dose adjustment period of 4 weeks followed by long term maintenance treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pardoprunox | Drug | 1.5 to 12 mg/day |
| |
| pramipexole |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in ON-time without dyskinesia | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4 | 16 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Juliana Bronzova, MD | Abbott Healthcare Products B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 45433 | Göttingen | 37075 | Germany | |||
| Site Reference ID/Investigator# 45428 |
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| Drug |
0.75-4.5 mg/day |
|
| Kassel |
| 34128 |
| Germany |
| Site Reference ID/Investigator# 45422 | Tübingen | BW 72076 | Germany |
| Site Reference ID/Investigator# 45427 | Ulm | 89081 | Germany |
| Site Reference ID/Investigator# 45435 | Cassino | 03043 | Italy |
| Site Reference ID/Investigator# 45436 | Chieti Scalo | 66013 | Italy |
| Site Reference ID/Investigator# 45437 | Rome | 00163 | Italy |
| Site Reference ID/Investigator# 45438 | Coimbra | 3000-075 | Portugal |
| Site Reference ID/Investigator# 45439 | Lisbon | 1649-035 | Portugal |
| 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 |
|---|---|
| C480679 | pardoprunox |
| 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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