Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00595920
Status:
TERMINATED
Last Update Posted:
2016-03-15
First Post:
2008-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540587', 'term': 'tovaxin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kfrazier@opexatherapeutics.com', 'phone': '281-775-0660', 'title': 'Kenny Frazier, VP of Clinical Development and Regulatory Affairs', 'organization': 'Opexa Therapeutics, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Open Label Extension', 'description': '30-45 million autologous myelin reactive T cells\n\nTovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.', 'otherNumAtRisk': 38, 'otherNumAffected': 25, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site reaction-Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction-Disomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction-Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction-Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction-Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Extension', 'description': '30-45 million autologous myelin reactive T cells\n\nTovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.'}], 'timeFrame': 'Annually', 'description': 'This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.', 'reportingStatus': 'POSTED', 'populationDescription': 'This extension study was discontinued due to financial constraints. No efficacy results are summarized due to the small number of patients who received full treatment and follow-up.'}, {'type': 'SECONDARY', 'title': 'Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression', 'timeFrame': 'Annually', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Changes in Annualized Relapse Rate', 'timeFrame': 'Annually', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label Extension', 'description': '30-45 million autologous myelin reactive T cells\n\nTovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': 'Patients Dosed', 'achievements': [{'comment': '116 patients enrolled; however, only 38 received at least 1 dose.', 'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}], 'dropWithdraws': [{'type': 'The OLTERMS study was discontinued by th', 'reasons': [{'groupId': 'FG000', 'numSubjects': '116'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label Extension', 'description': '30-45 million autologous myelin reactive T cells\n\nTovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.98', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '57'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomized and received at least one dose.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'whyStopped': 'Financial Constraints', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2008-01-03', 'resultsFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2008-01-04', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-16', 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)', 'timeFrame': 'Annually', 'description': 'This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.'}], 'secondaryOutcomes': [{'measure': 'Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression', 'timeFrame': 'Annually'}, {'measure': 'Evaluate Changes in Annualized Relapse Rate', 'timeFrame': 'Annually'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tovaxin', 'Autologous', 'T-cell vaccine (TCV)'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting', 'Clinically Isolated Syndrome']}, 'referencesModule': {'references': [{'pmid': '11642613', 'type': 'BACKGROUND', 'citation': 'Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.'}, {'pmid': '11985389', 'type': 'BACKGROUND', 'citation': 'Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.'}, {'pmid': '12901569', 'type': 'BACKGROUND', 'citation': 'Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.', 'detailedDescription': 'The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who completed the TERMS study and received at least 1 study treatment injection\n* Signed and dated statement of informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study.\n* Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments.\n* Non-compliant with TERMS study.\n* Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study.\n* Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study.\n* Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study."}, 'identificationModule': {'nctId': 'NCT00595920', 'acronym': 'OLTERMS', 'briefTitle': 'Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Opexa Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00', 'orgStudyIdInfo': {'id': '2007-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tovaxin, open-label', 'description': 'Tovaxin; 30-45 million autologous myelin reactive T cells', 'interventionNames': ['Biological: Tovaxin']}], 'interventions': [{'name': 'Tovaxin', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous TCV', 'T Cell Vaccine'], 'description': '2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.', 'armGroupLabels': ['Tovaxin, open-label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates, PC', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Xenoscience - 21st Century Neurology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - East Bay Physicians Medical Group', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '80919', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Patricia A Fodor, PC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bradenton Neurology', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Associates', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia - Department of Neurology', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants in Neurology, Ltd.', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '46805', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Allied Physicians Inc', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'MidAmerica Neuroscience Institute', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Associates in Neurology', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': "St Mary's of Michigan - Field Neuroscience Institute", 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Ayres & Associates Clinical Trials', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Clinical Research, LLC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital - Clinical Trials Unit', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Neurology Consultants of the Carolinas, PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44302', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology & Neuroscience Associates, Inc.', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurological Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45408', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology Specialists, Inc', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center - Northwest MS Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Maxine Mesinger MS Clinic/Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Neurology', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Integra Clinical Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98101', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'MS Center at Evergreen', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}], 'overallOfficials': [{'name': 'Edward J Fox, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Texas Neurology Consultants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Opexa Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}