Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT01545518
Status:
TERMINATED
Last Update Posted:
2014-09-01
First Post:
2011-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
IVIG Treatment for Refractory Immune-Related Adult Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D020363', 'term': 'Limbic Encephalitis'}, {'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cepstei@emory.edu', 'phone': '404-778-3633', 'title': 'Dr. Charles M. Epstein', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was terminated early. Subject eligibility for phase 2 not available.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Subjects', 'description': "IVIG\n\nIVIG: IVIG 2 mg/kg in two divided doses with placebo crossover\n\nNo AE's.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immune Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'IVIG\n\nIVIG: IVIG 2 mg/kg in two divided doses with placebo crossover'}], 'timeFrame': 'Screening visit', 'description': 'neuronal nuclear, cytoplasmic, and cell surface autoantibodies', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'IVIG\n\nIVIG: IVIG 2 mg/kg in two divided doses with placebo crossover'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients enrolled in a medical setting if eligible. Inclusion and exclusion criteria. A total of 20 patients with unexplained refractory epilepsy were screened and tested with a multiple panel for anti-neuronal antibodies.', 'preAssignmentDetails': 'In comparisons with our original futility criteria, it was apparent that the absence of more powerful findings, and the time it took to collect the ones we have, indicated the virtual impossibility of identifying enough patients with strong autoimmune findings to carry out Phase 2 of this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'IVIG\n\nIVIG: IVIG 2 mg/kg in two divided doses with placebo crossover'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', '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': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '18-50 years of age, both male and female'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Futility criteria, unable for Phase 2 of study, \\& phase 1 was terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2011-11-30', 'resultsFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-21', 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune Abnormalities', 'timeFrame': 'Screening visit', 'description': 'neuronal nuclear, cytoplasmic, and cell surface autoantibodies'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Refractory epilepsy', 'Cryptogenic epilepsy', 'Autoimmune disorders', 'IVIG', 'Immunomodulatory therapy', 'Autoantibodies'], 'conditions': ['Epilepsy, Cryptogenic', 'Epilepsy, Partial', 'Seizure Disorder', 'Autoimmune Diseases, Nervous System', 'Limbic Encephalitis']}, 'referencesModule': {'references': [{'pmid': '9217677', 'type': 'BACKGROUND', 'citation': 'Alamowitch S, Graus F, Uchuya M, Rene R, Bescansa E, Delattre JY. Limbic encephalitis and small cell lung cancer. Clinical and immunological features. Brain. 1997 Jun;120 ( Pt 6):923-8. doi: 10.1093/brain/120.6.923.'}, {'pmid': '11353730', 'type': 'BACKGROUND', 'citation': 'Graus F, Keime-Guibert F, Rene R, Benyahia B, Ribalta T, Ascaso C, Escaramis G, Delattre JY. Anti-Hu-associated paraneoplastic encephalomyelitis: analysis of 200 patients. Brain. 2001 Jun;124(Pt 6):1138-48. doi: 10.1093/brain/124.6.1138.'}, {'pmid': '10869059', 'type': 'BACKGROUND', 'citation': 'Gultekin SH, Rosenfeld MR, Voltz R, Eichen J, Posner JB, Dalmau J. Paraneoplastic limbic encephalitis: neurological symptoms, immunological findings and tumour association in 50 patients. Brain. 2000 Jul;123 ( Pt 7):1481-94. doi: 10.1093/brain/123.7.1481.'}, {'pmid': '12873758', 'type': 'BACKGROUND', 'citation': 'Jacobs DA, Fung KM, Cook NM, Schalepfer WW, Goldberg HI, Stecker MM. Complex partial status epilepticus associated with anti-Hu paraneoplastic syndrome. J Neurol Sci. 2003 Sep 15;213(1-2):77-82. doi: 10.1016/s0022-510x(03)00130-8.'}, {'pmid': '14601695', 'type': 'BACKGROUND', 'citation': 'Lawn ND, Westmoreland BF, Kiely MJ, Lennon VA, Vernino S. Clinical, magnetic resonance imaging, and electroencephalographic findings in paraneoplastic limbic encephalitis. Mayo Clin Proc. 2003 Nov;78(11):1363-8. doi: 10.4065/78.11.1363.'}, {'pmid': '9521251', 'type': 'BACKGROUND', 'citation': 'Lucchinetti CF, Kimmel DW, Lennon VA. Paraneoplastic and oncologic profiles of patients seropositive for type 1 antineuronal nuclear autoantibodies. Neurology. 1998 Mar;50(3):652-7. doi: 10.1212/wnl.50.3.652.'}, {'pmid': '19204167', 'type': 'BACKGROUND', 'citation': 'McKeon A, Ahlskog JE, Britton JW, Lennon VA, Pittock SJ. Reversible extralimbic paraneoplastic encephalopathies with large abnormalities on magnetic resonance images. Arch Neurol. 2009 Feb;66(2):268-71. doi: 10.1001/archneurol.2008.556.'}, {'pmid': '18195661', 'type': 'BACKGROUND', 'citation': 'Nahab F, Heller A, Laroche SM. Focal cortical resection for complex partial status epilepticus due to a paraneoplastic encephalitis. Neurologist. 2008 Jan;14(1):56-9. doi: 10.1097/NRL.0b013e3181578952.'}, {'pmid': '15468074', 'type': 'BACKGROUND', 'citation': 'Pittock SJ, Kryzer TJ, Lennon VA. Paraneoplastic antibodies coexist and predict cancer, not neurological syndrome. Ann Neurol. 2004 Nov;56(5):715-9. doi: 10.1002/ana.20269.'}, {'pmid': '11422434', 'type': 'BACKGROUND', 'citation': 'Porta-Etessam J, Ruiz-Morales J, Millan JM, Ramos A, Martinez-Salio A, Berbel-Garcia A. Epilepsia partialis continua and frontal features as a debut of anti-Hu paraneoplastic encephalomyelitis with focal frontal encephalitis. Eur J Neurol. 2001 Jul;8(4):359-60. doi: 10.1046/j.1468-1331.2001.00213.x. No abstract available.'}, {'pmid': '9989630', 'type': 'BACKGROUND', 'citation': 'Shavit YB, Graus F, Probst A, Rene R, Steck AJ. Epilepsia partialis continua: a new manifestation of anti-Hu-associated paraneoplastic encephalomyelitis. Ann Neurol. 1999 Feb;45(2):255-8. doi: 10.1002/1531-8249(199902)45:23.0.co;2-n.'}, {'pmid': '15079019', 'type': 'BACKGROUND', 'citation': 'Thieben MJ, Lennon VA, Boeve BF, Aksamit AJ, Keegan M, Vernino S. Potentially reversible autoimmune limbic encephalitis with neuronal potassium channel antibody. Neurology. 2004 Apr 13;62(7):1177-82. doi: 10.1212/01.wnl.0000122648.19196.02.'}, {'pmid': '17898866', 'type': 'BACKGROUND', 'citation': 'Matarasso N, Bar-Shira A, Rozovski U, Rosner S, Orr-Urtreger A. Functional analysis of the Aurora Kinase A Ile31 allelic variant in human prostate. Neoplasia. 2007 Sep;9(9):707-15. doi: 10.1593/neo.07322.'}, {'pmid': '21570256', 'type': 'BACKGROUND', 'citation': 'Rudzinski LA, Pittock SJ, McKeon A, Lennon VA, Britton JW. Extratemporal EEG and MRI findings in ANNA-1 (anti-Hu) encephalitis. Epilepsy Res. 2011 Aug;95(3):255-62. doi: 10.1016/j.eplepsyres.2011.04.006. Epub 2011 May 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).\n\nThe study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.\n\nAt present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.', 'detailedDescription': 'The study is divided into two phases:\n\nPhase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons.\n\nPhase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months.\n* Age 18 to 50.\n* Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy.\n* Refractory to an adequate trial of two or more main-line anti-epileptic drugs.\n* Ability to keep a seizure diary.\n* Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis\n\nExclusion Criteria:\n\n* History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects.\n* Evidence of psychogenic epilepsy.\n* History of convulsive status epilepticus.\n* History of primary generalized epilepsy in a first degree relative.\n* Known serious medical illness.'}, 'identificationModule': {'nctId': 'NCT01545518', 'briefTitle': 'IVIG Treatment for Refractory Immune-Related Adult Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'IVIG Treatment for Refractory Immune-Related Adult Epilepsy', 'orgStudyIdInfo': {'id': 'IRB00052646'}, 'secondaryIdInfos': [{'id': 'BT11-000312', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'all subjects', 'description': 'IVIG', 'interventionNames': ['Drug: IVIG']}], 'interventions': [{'name': 'IVIG', 'type': 'DRUG', 'otherNames': ['IVIG manufactured by Baxter Healthcare Corporation'], 'description': 'IVIG 2 mg/kg in two divided doses with placebo crossover', 'armGroupLabels': ['all subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Charles M. Epstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professsor of Neurology - Divsion of Epilepsy', 'investigatorFullName': 'Charles M. Epstein, MD', 'investigatorAffiliation': 'Emory University'}}}}