Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT00125567
Status:
COMPLETED
Last Update Posted:
2009-06-22
First Post:
2005-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stalevo in Early Wearing-Off Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C481098', 'term': 'Stalevo'}, {'id': 'D007980', 'term': 'Levodopa'}, {'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-19', 'studyFirstSubmitDate': '2005-07-29', 'studyFirstSubmitQcDate': '2005-07-29', 'lastUpdatePostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms', 'timeFrame': 'Up to 2 years of treatment'}], 'secondaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale", 'timeFrame': 'Up to 2 years of treatment'}, {'measure': 'Clinical Global Impression of Change (investigator)', 'timeFrame': 'Up to 2 years of treatment'}, {'measure': "Parkinson's Disease Questionnaire (PDQ-39)", 'timeFrame': 'Up to 2 years of treatment'}, {'measure': 'Work Impairment Questionnaire', 'timeFrame': 'Up to 2 years of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Idiopathic Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic Parkinson's disease\n* Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day\n* Unchanged antiparkinsonian medication for 6 weeks prior to baseline\n\nExclusion Criteria:\n\n* Secondary or atypical parkinsonism\n* Patients with daily unpredictable OFF periods or painful dyskinesia"}, 'identificationModule': {'nctId': 'NCT00125567', 'acronym': 'SEWOP', 'briefTitle': 'Stalevo in Early Wearing-Off Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': "Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off", 'orgStudyIdInfo': {'id': '2939111'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2004-005234-39'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Stalevo (levodopa/carbidopa/entacapone)', 'interventionNames': ['Drug: Stalevo (levodopa/carbidopa/entacapone)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Levodopa/carbidopa', 'interventionNames': ['Drug: Levodopa/carbidopa']}], 'interventions': [{'name': 'Stalevo (levodopa/carbidopa/entacapone)', 'type': 'DRUG', 'description': 'Oral, 50-150 mg levodopa four times daily, for up to 2 years', 'armGroupLabels': ['1']}, {'name': 'Levodopa/carbidopa', 'type': 'DRUG', 'description': 'Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-9000 Aalborg', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '8000', 'city': 'Nørrebrogade 44', 'country': 'Denmark', 'facility': 'Århus Kommunehospital'}, {'city': 'Lappeenranta', 'country': 'Finland', 'facility': 'South Karelia Central Hospital', 'geoPoint': {'lat': 61.05871, 'lon': 28.18871}}, {'zip': '33521 Tampere', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '61231 Bad Nauheim', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Parkinson Klinik Bad Nauheim', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '97616 Bad Neustadt', 'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Neurologische Klinik Bad Neustadt', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'zip': '40225 Duesseldorf', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Neurologische Klinik der Universitat Dusseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '21075 Hamburg', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Allgemeines Krankenhaus Harburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '89073 Ulm', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Praxis Drs Lang, Krauss, Schreiber', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': 'Dublin 7', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Private Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'SE-205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Universitetssjukhuset MAS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': 'SE-162 68', 'city': 'Vällingby', 'country': 'Sweden', 'facility': 'Läkarhuset Vällingby', 'geoPoint': {'lat': 59.36441, 'lon': 17.87407}}, {'zip': 'KT16 0QA', 'city': 'Chertsey', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Movement Disorder Services', 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CF14 4XW', 'city': 'Rhyl', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'zip': 'BS16 1LE', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Frenchay Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'WN7 1HS', 'city': 'Leigh', 'country': 'United Kingdom', 'facility': 'Leigh Infirmary', 'geoPoint': {'lat': 53.49642, 'lon': -2.51973}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Andrew Wighton, BSc (Hons)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orion Corporation, Orion Pharma'}, {'name': 'Bhadravati SD Sastry, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Wales and Rookwood Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Andrew Wighton', 'oldOrganization': 'Orion Pharma'}}}}