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Sponsored by: |
Orion Corporation, Orion Pharma |
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Information provided by: | Orion Corporation, Orion Pharma |
ClinicalTrials.gov Identifier: | NCT00125567 |
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.
Condition | Intervention | Phase |
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Idiopathic Parkinson's Disease |
Drug: Stalevo (levodopa/carbidopa/entacapone) Drug: Levodopa/carbidopa |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off |
Estimated Enrollment: | 244 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Stalevo (levodopa/carbidope/entacapone)
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Drug: Stalevo (levodopa/carbidopa/entacapone)
Oral, 50-150 mg levodopa four times daily, for up to 2 years
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2: Active Comparator
Levodopa/carbidopa
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Drug: Levodopa/carbidopa
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
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Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Århus Kommunehospital | |
Nørrebrogade 44, Denmark, 8000 | |
Aalborg Hospital | |
Aalborg, Denmark, DK-9000 Aalborg | |
Bispebjerg Hospital | |
Copenhagen, Denmark | |
Finland | |
South Karelia Central Hospital | |
Lappeenranta, Finland | |
Tampere University Hospital | |
Tampere, Finland, 33521 Tampere | |
Germany | |
Allgemeines Krankenhaus Harburg | |
Hamburg, Germany, 21075 Hamburg | |
Neurologische Klinik Bad Neustadt | |
Bad Neustadt, Germany, 97616 Bad Neustadt | |
Parkinson Klinik Bad Nauheim | |
Bad Nauheim, Germany, 61231 Bad Nauheim | |
Praxis Drs Lang, Krauss, Schreiber | |
Ulm, Germany, 89073 Ulm | |
Neurologische Klinik der Universitat Dusseldorf | |
Duesseldorf, Germany, 40225 Duesseldorf | |
Ireland | |
Mater Private Hospital | |
Dublin, Ireland, Dublin 7 | |
Sweden | |
Läkarhuset Vällingby | |
Vällingby, Sweden, SE-162 68 | |
Universitetssjukhuset MAS | |
Malmö, Sweden, SE-205 02 | |
United Kingdom | |
Frenchay Hospital | |
Bristol, United Kingdom, BS16 1LE | |
Southampton General Hospital | |
Southampton, United Kingdom, SO16 6YD | |
Leigh Infirmary | |
Leigh, United Kingdom, WN7 1HS | |
United Kingdom, Surrey | |
Movement Disorder Services | |
Chertsey, Surrey, United Kingdom, KT16 0QA | |
United Kingdom, Wales | |
University Hospital of Wales | |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Glan Clwyd Hospital | |
Rhyl, Wales, United Kingdom, CF14 4XW |
Study Director: | Andrew Wighton, BSc (Hons) | Orion Corporation, Orion Pharma |
Principal Investigator: | Bhadravati SD Sastry, FRCP | University Hospital of Wales and Rookwood Hospital |
Responsible Party: | Orion Pharma ( Andrew Wighton ) |
Study ID Numbers: | 2939111, EudraCT number: 2004-005234-39 |
Study First Received: | July 29, 2005 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00125567 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Ireland: Irish Medicines Board; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Finland: National Agency for Medicines; Lithuania: State Medicine Control Agency - Ministry of Health |
Levodopa Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Carbidopa |
Basal Ganglia Diseases Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Entacapone |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Antiparkinson Agents Dopamine Agents Enzyme Inhibitors Central Nervous System Agents Pharmacologic Actions |