Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-21 @ 12:41 AM
Study NCT ID:
NCT02443350
Status:
UNKNOWN
Last Update Posted:
2015-05-13
First Post:
2015-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060426', 'term': 'Anti-N-Methyl-D-Aspartate Receptor Encephalitis'}], 'ancestors': [{'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': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-10', 'studyFirstSubmitDate': '2015-05-10', 'studyFirstSubmitQcDate': '2015-05-10', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': '24 months'}]}, 'conditionsModule': {'conditions': ['Anti-N-Methyl-D-Aspartate Receptor Encephalitis']}, 'referencesModule': {'references': [{'pmid': '32759178', 'type': 'DERIVED', 'citation': 'Peng Y, Dai F, Liu L, Chen W, Yan H, Liu A, Zhang X, Wang X, He J, Li Y, Li C, Chen L, Zhao Y, Li L, Ma Q, Wang J. Validation of the NEOS score in Chinese patients with anti-NMDAR encephalitis. Neurol Neuroimmunol Neuroinflamm. 2020 Aug 5;7(5):e860. doi: 10.1212/NXI.0000000000000860. Print 2020 Sep.'}]}, 'descriptionModule': {'briefSummary': "Anti N-methyl-D-aspartate receptor encephalitis is an autoimmune encephalitis，found in recent years，producing the specific IgG antibody induced by the NMDA receptors.It is the most common curable disease among the non infectious-autoimmune encephalitis,usually has been misdiagnosed as other causes of encephalitis.Our previous study found that there are differences between the Chinese and the foreign in anti-NMDA receptor encephalitis such as the sex ratio, the rate of combined tumor and clinical manifestations.As a new found disease,the incidence rate has been underestimated.Therefore,to establish the Registry Research Database for Chinese group of anti-NMDA receptor encephalitis is imminent.This study will combine Beijing area's hospitals and foreign experts,depending on multicenter, prospective and registry method,to understand the incidence in Beijing area,to summarize and analyze the clinical data of patients.So,there will make a solid foundation for the subsequent Beijing area detection platform and other research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The unexplained encephalitis patients in Beijing area', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 6 months.\n* Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;\n* At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;\n* Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear\n\nExclusion Criteria:\n\n* Infants less than 6 months;\n* The metabolic encephalopathy;\n* Infectious encephalitis with clinically clear pathogen, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;\n* Non-infectious encephalitis with clinically clear diagnosis, including: multiple sclerosis, optic neuromyelitis, acute disseminated encephalomyelitis and so on.'}, 'identificationModule': {'nctId': 'NCT02443350', 'acronym': 'MuPRaNE', 'briefTitle': 'Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'orgStudyIdInfo': {'id': 'CH 201411101'}}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Wei Wang, M.D', 'role': 'CONTACT', 'email': 'wangjwcq@163.com', 'phone': '(86)15910785840'}], 'facility': 'Beijing Tongren Hospital,Capital Medical Universiy', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jia Wei Wang, M.D', 'role': 'CONTACT', 'email': 'wangjwcq@163.com', 'phone': '(86)010-58268857'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jia Wei Wang,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.;The head of Department of Neurology and Medical Research Center', 'investigatorFullName': 'Jia Wei Wang,MD', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}