- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443350
Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area (MuPRaNE)
May 10, 2015 updated by: Jia Wei Wang,MD
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Beijing Tongren Hospital,Capital Medical Universiy
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Contact:
- Jia Wei Wang, M.D
- Phone Number: (86)15910785840
- Email: wangjwcq@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The unexplained encephalitis patients in Beijing area
Description
Inclusion Criteria:
- Older than 6 months.
- Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
- 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;
- Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear
Exclusion Criteria:
- Infants less than 6 months;
- The metabolic encephalopathy;
- Infectious encephalitis with clinically clear pathogen, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
- Non-infectious encephalitis with clinically clear diagnosis, including: multiple sclerosis, optic neuromyelitis, acute disseminated encephalomyelitis and so on.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
death
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
May 10, 2015
First Submitted That Met QC Criteria
May 10, 2015
First Posted (Estimate)
May 13, 2015
Study Record Updates
Last Update Posted (Estimate)
May 13, 2015
Last Update Submitted That Met QC Criteria
May 10, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Neurodegenerative Diseases
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Encephalitis
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Other Study ID Numbers
- CH 201411101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anti-N-Methyl-D-Aspartate Receptor Encephalitis
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Erasmus Medical CenterCompletedAnti-NMDA (N-Methyl D-Aspartate) Receptor EncephalitisNetherlands
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Arialys Australia Pty LtdSeoul National University Hospital; Arialys TherapeuticsRecruitingAutoimmune Encephalitis | Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE) | Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric DiseaseSouth Korea
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Arialys TherapeuticsCompletedAutoimmune Encephalitis | Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder) | Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor AntibodyAustralia
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Hospices Civils de LyonActive, not recruitingAnti NMDA Receptor EncephalitisFrance
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Charite University, Berlin, GermanyCompletedAnti-NMDA Receptor EncephalitisGermany
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Fundacion Clinic per a la Recerca BiomédicaHospital Sant Joan de DeuRecruitingAnti-NMDA Receptor EncephalitisSpain
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Assistance Publique - Hôpitaux de ParisRecruitingAnti-NMDAR EncephalitisFrance
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Beijing Tongren HospitalRecruitingAnti-N-Methyl-D-Aspartate Receptor EncephalitisChina
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The First People's Hospital of ChangzhouRecruitingAnti-N-Methyl-D-Aspartate Receptor EncephalitisChina
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Hospices Civils de LyonRecruitingNMDAR Antibody-associated Auto-immune EncephalitisFrance