Anti-N-Methyl-D-Aspartate Receptor EncephalitisMuPRaNENCT02443350
Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area
An observational study of Anti-N-Methyl-D-Aspartate Receptor Encephalitis, run by Jia Wei Wang,MD at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to May 2017
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The unexplained encephalitis patients in Beijing area
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital,Capital Medical Universiy
Beijing, Beijing Municipality, 100730
Jia Wei Wang, M.D, (86)15910785840, wangjwcq@163.com
About this study
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.
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-N-Methyl-D-Aspartate Receptor EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Jia Wei Wang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia Wei Wang,MD, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443350
- Sponsor's protocol ID
- CH 201411101
- Acronym
- MuPRaNE
- Status last verified
- May 2015
- First submitted
- 10 May 2015
- Last updated
- 13 May 2015
- Results posted
- No
Publications
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.
PubMed 32759178
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area
- ClinicalTrials.gov ID
- NCT02443350
- Acronym / sponsor ID
- MuPRaNE / CH 201411101
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jia Wei Wang,MDUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2017 (estimated)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The unexplained encephalitis patients in Beijing area
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Derived from this study: PubMed 32759178Peng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-N-Methyl-D-Aspartate Receptor Encephalitis, run by Jia Wei Wang,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Wei Wang, M.D ((86)010-58268857, wangjwcq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02443350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.