Anti NMDA Receptor EncephalitisBio-NMDArNCT05738668
Clinical-immunological Features of Anti-NMDAR Encephalitis
An observational study of Anti NMDA Receptor Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anti NMDA Receptor Encephalitis
- What is being tested?
- Description of clinical characteristic
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 1 Feb 2025
- 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 Any age
- Child, Adult, Older adult
Study population: Patients with well-characterized anti-NMDAR encephalitis
Who may be able to join
- Patient with neurological disorder
- Patient with NMDAR antibodies in sera or CSF
Who cannot join
- - No available clinical data
- Patient without NMDAR antibodies or neurological disorder
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
Lyon, BRON, 69677
About this study
Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers
- Conditions
- Anti NMDA Receptor Encephalitis
- Being tested
- Description of clinical characteristic
- Keywords
- Anti NMDA Receptor Encephalitis, antibodies, relapses, outcomes
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of clinical characteristicOther
This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.
| Study group | Role | What they receive |
|---|---|---|
| Anti-NMDAR encephalitis | Patients with well-characterized anti-NMDAR encephalitis. Receives: Other: Description of clinical characteristic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale (mRS)
Scale for measuring the degree of dependence in the daily activities of people who have suffered of neurological disability.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Feb 2022
- Primary completion1 Oct 2022
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti NMDA Receptor EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738668
- Sponsor's protocol ID
- 750
- Acronym
- Bio-NMDAr
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-immunological Features of Anti-NMDAR Encephalitis
- ClinicalTrials.gov ID
- NCT05738668
- Acronym / sponsor ID
- Bio-NMDAr / 750
- Conditions
- Anti NMDA Receptor Encephalitis
- Keywords
- Anti NMDA Receptor Encephalitis, antibodies, relapses, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 22 Feb 2023 (actual)
- 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.
Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-NMDAR encephalitis | – | Other: Description of clinical characteristicPatients with well-characterized anti-NMDAR encephalitis. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with well-characterized anti-NMDAR encephalitis
Key inclusion criteria (2 listed)
- Patient with neurological disorder
- Patient with NMDAR antibodies in sera or CSF
Key exclusion criteria (2 listed)
- - No available clinical data
- Patient without NMDAR antibodies or neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Description of clinical characteristicThis is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study. | Other | Anti-NMDAR encephalitis |
Primary outcome
Modified Rankin scale (mRS)
Time frame: Baseline
Scale for measuring the degree of dependence in the daily activities of people who have suffered of neurological disability. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NMDA Receptor Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 2 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 22 Feb 2023. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale (mRS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2023.