Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area

Anti-N-Methyl-D-Aspartate Receptor Encephalitis Clinical Trial

— MuPRaNE  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02443350
• Other study ID #: CH 201411101
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2015
• Last updated: May 10, 2015
• Start date: June 2014

Study information

• Verified date: May 2015
• Source: Beijing Tongren Hospital
• Contact: Jia Wei Wang, M.D
• Phone: (86)010-58268857
• Email: wangjwcq[@]163.com
• Is FDA regulated: No
• Health authority: The science and technology committee of Beijing:China
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anti-N-Methyl-D-Aspartate Receptor Encephalitis
• Encephalitis

Locations

Country	Name	City	State
China	Beijing Tongren Hospital,Capital Medical Universiy	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jia Wei Wang,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death		24 months	No