Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-07 @ 2:45 AM
Study NCT ID:
NCT04867551
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of adverse events', 'timeFrame': '8 weeks', 'description': 'The numbers of events and subjects, the incidence regarding adverse events.'}, {'measure': 'Plasma concentrations of KDT-3594 and its metabolites', 'timeFrame': '8 weeks', 'description': 'Plasma concentrations of KDT-3594 and its metabolites during treatment period.'}], 'secondaryOutcomes': [{'measure': "Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)", 'timeFrame': '8 weeks', 'description': 'Change from baseline (Week 0) in MDS-UPDRS total score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Objective of this study is to investigate the safety, pharmacokinetics and efficacy of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Japanese patients\n* Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria\n* Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale\n\nExclusion Criteria:\n\n* Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease.\n* Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study\n* Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score \\< 24 points"}, 'identificationModule': {'nctId': 'NCT04867551', 'briefTitle': "A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': "A Phase II Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease", 'orgStudyIdInfo': {'id': 'KDT1202A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KDT-3594', 'interventionNames': ['Drug: KDT-3594']}], 'interventions': [{'name': 'KDT-3594', 'type': 'DRUG', 'description': 'oral administration, dose titration', 'armGroupLabels': ['KDT-3594']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'Yoshitaka Shimizu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kissei Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}