Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT00212693
Status:
COMPLETED
Last Update Posted:
2012-10-11
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's disease rating scale (Part III)"}], 'secondaryOutcomes': [{'measure': "Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time"}]}, 'conditionsModule': {'keywords': ["ONO-2506PO, Parkinson's disease"], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients with Parkinson's Disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of Parkinson's disease\n2. Stage 2 - Stage 4 of revised Hoehn \\& Yahr severity score\n3. Taking L-dopa/DCI without changing dose and regimen\n4. Having motor complication\n5. Other inclusion criteria as specified in the study protocol\n\nExclusion Criteria:\n\n1. Previous participation in ONO-2506PO or ONO-2506 protocol\n2. Previous brain surgery for Parkinson's disease\n3. Presence or history of serious cardiac disease\n4. Other exclusion criteria as specified in the study protocol"}, 'identificationModule': {'nctId': 'NCT00212693', 'briefTitle': "Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan", 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': "Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan", 'orgStudyIdInfo': {'id': 'ONO-2506PO-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ONO-2506PO', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Project Leader, Development Planning', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}