Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
223 participants
INTERVENTIONAL
2005-08-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Stalevo (levodopa/carbidopa/entacapone)
Stalevo (levodopa/carbidopa/entacapone)
Oral, 50-150 mg levodopa four times daily, for up to 2 years
2
Levodopa/carbidopa
Levodopa/carbidopa
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
Interventions
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Stalevo (levodopa/carbidopa/entacapone)
Oral, 50-150 mg levodopa four times daily, for up to 2 years
Levodopa/carbidopa
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
Eligibility Criteria
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Inclusion Criteria
* Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
* Unchanged antiparkinsonian medication for 6 weeks prior to baseline
Exclusion Criteria
* Patients with daily unpredictable OFF periods or painful dyskinesia
30 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Orion Pharma
Principal Investigators
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Andrew Wighton, BSc (Hons)
Role: STUDY_DIRECTOR
Orion Corporation, Orion Pharma
Bhadravati SD Sastry, FRCP
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Wales and Rookwood Hospital
Locations
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Aalborg Hospital
Aalborg, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Århus Kommunehospital
Nørrebrogade 44, , Denmark
South Karelia Central Hospital
Lappeenranta, , Finland
Tampere University Hospital
Tampere, , Finland
Parkinson Klinik Bad Nauheim
Bad Nauheim, , Germany
Neurologische Klinik Bad Neustadt
Bad Neustadt an der Saale, , Germany
Neurologische Klinik der Universitat Dusseldorf
Düsseldorf, , Germany
Allgemeines Krankenhaus Harburg
Hamburg, , Germany
Praxis Drs Lang, Krauss, Schreiber
Ulm, , Germany
Mater Private Hospital
Dublin, , Ireland
Universitetssjukhuset MAS
Malmo, , Sweden
Läkarhuset Vällingby
Vällingby, , Sweden
Movement Disorder Services
Chertsey, Surrey, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Glan Clwyd Hospital
Rhyl, Wales, United Kingdom
Frenchay Hospital
Bristol, , United Kingdom
Leigh Infirmary
Leigh, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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EudraCT number: 2004-005234-39
Identifier Type: -
Identifier Source: secondary_id
2939111
Identifier Type: -
Identifier Source: org_study_id
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