Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 10:53 AM
Study NCT ID:
NCT00957203
Status:
COMPLETED
Last Update Posted:
2012-08-31
First Post:
2009-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease 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': 'C111599', 'term': 'istradefylline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-30', 'studyFirstSubmitDate': '2009-08-07', 'studyFirstSubmitQcDate': '2009-08-11', 'lastUpdatePostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events'}], 'secondaryOutcomes': [{'measure': 'Reducing the mean total hours of awake time per day spent in the OFF state'}, {'measure': 'Reducing the mean percentage of awake time per day spent in the OFF state'}, {'measure': 'Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)'}, {'measure': "Change in Unified Parkinson's Disease Rating Scale (UPDRS)"}, {'measure': 'Change in the Clinical Global Impression - Improvement scale (CGI-I)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'levodopa', 'end of dose wearing off', 'OFF time'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be willing and able to give written informed consent\n2. Completion of the study 6002-009\n\nExclusion Criteria:\n\n1. Mini-mental status examination score of 23 or less\n2. Less than 70% of compliance in the study 6002-009\n3. Emergency deviation in the study 6002-009\n4. Pregnant females'}, 'identificationModule': {'nctId': 'NCT00957203', 'acronym': '6002-010', 'briefTitle': "Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': "Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)", 'orgStudyIdInfo': {'id': '6002-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Istradefylline', 'interventionNames': ['Drug: Istradefylline']}], 'interventions': [{'name': 'Istradefylline', 'type': 'DRUG', 'otherNames': ['KW-6002'], 'description': 'Oral istradefylline (KW-6002) 20 or 40 mg once daily', 'armGroupLabels': ['Istradefylline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyowa Kirin Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}