Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-06 @ 11:22 AM
Study NCT ID:
NCT00146159
Status:
TERMINATED
Last Update Posted:
2007-12-28
First Post:
2005-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Mitoxantrone in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008942', 'term': 'Mitoxantrone'}], 'ancestors': [{'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 336}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'lastUpdateSubmitDate': '2007-12-21', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)', 'timeFrame': '3 years'}, {'measure': 'deterioration, change of ambulation index, time to first relapse requiring corticoid treatment', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'derivations of EDSS and relapses; MRI (baseline, 2 years)', 'timeFrame': '3 years'}]}, 'conditionsModule': {'keywords': ['Multiple Sclerosis'], 'conditions': ['Secondary Progressive Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Secondary progressive MS in an active stage\n* EDSS between 3 and 6\n\nExclusion Criteria:\n\n* Benign or primary progressive MS\n* Patients with cardiac risk factors\n* Patients who have already received mitoxantrone'}, 'identificationModule': {'nctId': 'NCT00146159', 'briefTitle': 'Study Evaluating Mitoxantrone in Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': '0906E-100925'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '1st group: 12 mg Mitoxantrone/m²', 'interventionNames': ['Drug: Mitoxantrone']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '2nd group: 9mg Mitoxantrone/m²', 'interventionNames': ['Drug: Mitoxantrone']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '3rd group: 5mg Mitoxantrone/m²', 'interventionNames': ['Drug: Mitoxantrone']}], 'interventions': [{'name': 'Mitoxantrone', 'type': 'DRUG', 'description': 'dosage', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-82335', 'city': 'Berg', 'country': 'Germany', 'geoPoint': {'lat': 49.81417, 'lon': 12.14161}}, {'zip': 'D-13347', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-40225', 'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': 'D-40479', 'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': 'D-35385', 'city': 'Giessen', 'country': 'Germany', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': 'D-35039', 'city': 'Marburg', 'country': 'Germany', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': 'D-65191', 'city': 'Wiesbaden', 'country': 'Germany', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Clinical Trials Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}