Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 7:04 AM
Study NCT ID:
NCT01384435
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2011-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}], 'ancestors': [{'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Scale for the assessment and rating of ataxia (SARA)', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in patient improvement impression of activities of daily living', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinocerebellar degeneration (SCD)', 'Thyrotropin-Releasing Hormone (TRH)'], 'conditions': ['SCD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese SCD patients with mild to moderate ataxia\n\nExclusion Criteria:\n\n* Patients with secondary ataxia\n* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction'}, 'identificationModule': {'nctId': 'NCT01384435', 'briefTitle': 'A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD', 'orgStudyIdInfo': {'id': 'KPS1203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KPS-0373, lowest dose', 'interventionNames': ['Drug: KPS-0373']}, {'type': 'EXPERIMENTAL', 'label': 'KPS-0373, 2nd lowest dose', 'interventionNames': ['Drug: KPS-0373']}, {'type': 'EXPERIMENTAL', 'label': 'KPS-0373, 2nd highest dose', 'interventionNames': ['Drug: KPS-0373']}, {'type': 'EXPERIMENTAL', 'label': 'KPS-0373, highest dose', 'interventionNames': ['Drug: KPS-0373']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KPS-0373', 'type': 'DRUG', 'armGroupLabels': ['KPS-0373, lowest dose']}, {'name': 'KPS-0373', 'type': 'DRUG', 'armGroupLabels': ['KPS-0373, 2nd lowest dose']}, {'name': 'KPS-0373', 'type': 'DRUG', 'armGroupLabels': ['KPS-0373, 2nd highest dose']}, {'name': 'KPS-0373', 'type': 'DRUG', 'armGroupLabels': ['KPS-0373, highest dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo and Other Japanese City', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Katsumi Hontani', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Dept.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}