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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2004-005234-39 |
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The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Stalevo (levodopa/carbidopa/entacapone) |
|
| 2 | Active Comparator | Levodopa/carbidopa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stalevo (levodopa/carbidopa/entacapone) | Drug | Oral, 50-150 mg levodopa four times daily, for up to 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms | Up to 2 years of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale | Up to 2 years of treatment | |
| Clinical Global Impression of Change (investigator) | Up to 2 years of treatment | |
| Parkinson's Disease Questionnaire (PDQ-39) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Wighton, BSc (Hons) | Orion Corporation, Orion Pharma | Study Director |
| Bhadravati SD Sastry, FRCP | University Hospital of Wales and Rookwood Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Hospital | Aalborg | DK-9000 Aalborg | Denmark | |||
| Bispebjerg Hospital |
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| Levodopa/carbidopa | Drug | Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years |
|
| Up to 2 years of treatment |
| Work Impairment Questionnaire | Up to 2 years of treatment |
| Copenhagen |
| Denmark |
| Århus Kommunehospital | Nørrebrogade 44 | 8000 | Denmark |
| South Karelia Central Hospital | Lappeenranta | Finland |
| Tampere University Hospital | Tampere | 33521 Tampere | Finland |
| Parkinson Klinik Bad Nauheim | Bad Nauheim | 61231 Bad Nauheim | Germany |
| Neurologische Klinik Bad Neustadt | Bad Neustadt an der Saale | 97616 Bad Neustadt | Germany |
| Neurologische Klinik der Universitat Dusseldorf | Düsseldorf | 40225 Duesseldorf | Germany |
| Allgemeines Krankenhaus Harburg | Hamburg | 21075 Hamburg | Germany |
| Praxis Drs Lang, Krauss, Schreiber | Ulm | 89073 Ulm | Germany |
| Mater Private Hospital | Dublin | Dublin 7 | Ireland |
| Universitetssjukhuset MAS | Malmö | SE-205 02 | Sweden |
| Läkarhuset Vällingby | Vällingby | SE-162 68 | Sweden |
| Movement Disorder Services | Chertsey | Surrey | KT16 0QA | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| Glan Clwyd Hospital | Rhyl | Wales | CF14 4XW | United Kingdom |
| Frenchay Hospital | Bristol | BS16 1LE | United Kingdom |
| Leigh Infirmary | Leigh | WN7 1HS | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| 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 |
|---|---|
| C481098 | Stalevo |
| D007980 | Levodopa |
| C009265 | carbidopa, levodopa drug combination |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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