Acute Disseminated EncephalomyelitisHOT-BRAINNCT06863974
High-throughput Omic Technology for Identification of Biomarkers of Relapsing Acute Disseminated Encephalomyelitis in Immune Cell Network
A study testing Blood test in people with Acute Disseminated Encephalomyelitis and Encephalitis Autoimmune, run by University Hospital, Angers at 8 sites in France.
Trial summary
Acute disseminated encephalomyelitis (ADEM) is a neuroinflammatory disorder of the central nervous system, manifesting itself as impaired consciousness, even to the point of coma, and multifocal neurological deficits. ADEM is the most common encephalitis in children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Disseminated Encephalomyelitis, Encephalitis Autoimmune
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesFrance
- Study dates
- 16 Nov 2025to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective recruitment Pre-inclusion criteria
- Age at inclusion between 1 and 18 years (included)
- First demyelinating event at inclusion, such as ADEM encephalitis, optic neuritis (NORB) or myelitis, or a combination of these conditions.
- Informed consent signed by patient's legal representative
- Patient affiliated to or benefiting from a social security scheme Inclusion criteria (confirmation of inclusion and follow-up in one of 3 groups)
- MOGAD/ADEM group: presence of serum anti-MOG antibodies and diagnosis of ADEM (according to the International Pediatric Multiple Sclerosis Society Group (IPMSSG) criteria revised in 2013) at the first demyelinating attack.
Show all 23Show fewer
- Non-MOGAD/ADEM group: anti-MOG antibodies negative and diagnosis of ADEM at first demyelinating attack.
- MOGAD/non-ADEM group: presence of serum anti-MOG antibodies and diagnosis of myelitis and/or NORB at first demyelinating attack.
- Retrospective recruitment General inclusion criteria
- Age at inclusion between 1 and 18 years (inclusive)
- Inclusion (signed consent of the patient's legal representative) in the biocollection from which the samples were taken at the latest at the time of management of a first demyelinating event of the ADEM encephalitis, optic neuritis (NORB) or myelitis type, or a combination of these disorders.
- PBMC collected at the time of the first demyelinating event before any immunomodulatory treatment, cryopreserved and available in the biocollection.
- Depending on the date of inclusion (if inclusion beyond 6 to 24 months after the first demyelinating event), samples taken at 6 months and then 24 months after the first demyelinating event available in the biocollection for the analyses planned in the study.
- Informed consent signed by patient's legal representative
- Patient affiliated to or benefiting from a social security scheme
- MOGAD/ADEM group: presence of serum anti-MOG antibodies and diagnosis of ADEM (according to the International Pediatric Multiple Sclerosis Society Group (IPMSSG) criteria revised in 2013) at the first demyelinating attack.
- Non-MOGAD/ADEM group: anti-MOG antibodies negative and diagnosis of ADEM at first demyelinating attack.
- MOGAD/non-ADEM group: presence of serum anti-MOG antibodies and diagnosis of myelitis and/or NORB at first demyelinating attack.
- Non-inclusion criteria (prospective or retrospective recruitment):
- Immunosuppressive therapy in the 6 months prior to treatment for a first demyelinating event.
- Systemic corticosteroid therapy or immunomodulating doses of IV polyvalent immunoglobulin or plasma exchange within 3 months prior to treatment for a first demyelinating event.
- Brain MRI not performed at diagnosis of first demyelinating event
- Poor understanding of the French language
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU d'Angers
Angers, 49240
Nail Benallegue, Doctor, +332 41 35 44 45, nail.benallegue@chu-angers.fr
- Recruiting
Univesity Hostipal of Brest
Brest, 29200
Juliette Ropars, MD, 33-(0)2-98-22-33-89, juliette.ropars@chu-brest.fr
- Recruiting
Univesity Hostipal of APHP
Le Kremlin-Bicêtre, 94270
Deiva Kumaran, MD, 33-(0)1-45-21-31-12, kumaran.deiva@aphp.fr
- Not yet recruiting
CHU Montpellier
Montpellier, 34295
Pierre MEYER, DR, +334 67 33 74 22, p-meyer@chu-montpellier.fr
- Recruiting
Univesity Hostipal of Nantes
Nantes, 44093
Capucine GLASSON, MD, 33-(0)2-40-16-51-76, capucine.lefebvre@chu-nantes.fr
- Not yet recruiting
Hôpital Necker Enfants Malades
Paris, 75015
Mélodie AUBART, DR, +331 42 19 26 93, melodie.aubart@aphp.fr
- Recruiting
Univesity Hostipal of Rennes
Rennes, 35000
Silvia Napuri-Peirano, MD, 33-(0)2-99-26-71-14, Silviaadriana.napuri.peirano@chu-rennes.fr
- Recruiting
Univesity Hostipal of Tours
Tours, 37000
Pierre Castelnau, MD, 33-(0)2-47-47-47-47, castelnau@univ-tours.fr
About this study
Official title: High-throughput Omic Technology for Identification of Biomarkers of Relapsing Acute Disseminated Encephalomyelitis in the Immune Cell Network
Acute disseminated encephalomyelitis (ADEM) is a neuroinflammatory disorder of the central nervous system, manifesting itself as impaired consciousness, even to the point of coma, and multifocal neurological deficits. ADEM is the most common encephalitis in children. Moreover, 50-65% of ADEM in children is associated with the presence of anti-MOG antibodies (MOGAD). In fact, ADEM is the most frequent clinical presentation of MOGAD in children, 50-75% before the age of 10. The risk of recurrence is higher in pediatric MOGAD of ADEM manifestation, up to 30%, compared to myelitis or optic neuritis. Multiphasic MOGAD are more frequently associated with sequelae in 50-69% of cases, versus 4-32% for monophasic forms. In ADEM, cognitive and epileptic sequelae predominate. The 2020 European consortium and the 2022 national diagnosis and care protocol recommend the introduction of disease-modifying therapies as early as the second attack of the disease, or in the event of distant sequelae, in order to limit relapses and sequelae. However, these treatments take several months to take effect.
There is currently no reliable predictive factor for MOGAD recurrence other than the persistence of an elevated blood anti-MOG antibody level (≥1:1280) at 1 year. The aim of this study is therefore to identify biomarkers associated with MOGAD recurrence from the first attack. To this end, we will study the transcriptome of circulating blood mononuclear cells by single-cell next-generation RNA sequencing in children with anti-MOGAD neuroinflammatory relapses. Anticipating the multiphasic trajectory of the disease would enable the introduction of early disease-modifying therapy to prevent recurrences and long-term sequelae. Furthermore, the discovery of a molecular and/or cellular signature would provide a better understanding of the pathophysiology of ADEM and MOGAD.
- Being tested
- Blood test
- Medical subject headings
- Encephalomyelitis, Acute Disseminated, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Drawing blood to realize biomarkers of disease course of MOGAD-ADEM and pathophysiology of ADEM (and MOGAD) : cellular and molecular signatures, inflammatory signaling.
| Study group | Role | What they receive |
|---|---|---|
| ADEM non-MOGAD | Experimental | Non-MOGAD ADEM control group of 5 patients with anti-MOG antibody-negative ADEM Receives: Other: Blood test |
| ADEM MOGAD | Active comparator | Single-phase and multi-phase ADEM MOGAD units respectively Receives: Other: Blood test |
| MOGAD non-ADEM | Experimental | MOGAD non-ADEM central nervous system demyelinating neuroinflammatory control group (anti-MOG antibody-positive optic neuritis or myelitis) of 5 patients Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sample
1 tube (approx. 5 mL) for children under 12 kg, 2 tubes (approx. 10 mL) for children between 12 kg and 20 kg, 4 tubes (approx. 20 mL) for children over 20 kg.
Collected tubes are transferred to the investigator's Biological Resource Center (BRC) for sample preparation of the biocollection, if accepted in the consent form, and preparation of circulating blood mononuclear cells (PBMC).
Measured: Inclusion, 6 months, 24 months
Age
Measured: Inclusion
Personal or family history of inflammatory or dysimmune disease
Measured: Inclusion
Weight
Weight (kg)
Measured: Inclusion, 6 months, 24 months
EDSS (Expanded Disability Status Scale)
The neurological examination is divided into eight functional systems, 4 major (pyramidal, cerebellar, sensory, brainstem), 4 minor (sphincter, vision, mental and other).
A numerical score of increasing severity (0 to 6 or 7) is given to each functional system (FS). The overall scale score is measured on a 20-level scale (0 to 10 per half-point). Up to level 3.5, the score obtained in each FS (Functional System) and the number of FS reached automatically determine the EDSS score. From 4 to 7, the definition of each level is also given by the walking disability (ability to walk without stopping, need for assistance).
Measured: Inclusion, 6 months, 24 months
Neurological episodes consistent with demyelinating relapse since previous visit
Number, date, neurological symptoms including chronic fatigue unusual for an individual of the same age, diagnosis of demyelinating relapse, type, hospitalization, treatment with intravenous corticosteroid bolus.
Measured: 6 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start16 Nov 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Disseminated EncephalomyelitisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective recruitment requires pre-inclusion because the characterization of antibodies allowing patients to be classified into these 3 groups is only done at a later stage.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nail BENALLEGUE, DOCTOR, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863974
- Sponsor's protocol ID
- 2024-A02732-45
- Acronym
- HOT-BRAIN
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-throughput Omic Technology for Identification of Biomarkers of Relapsing Acute Disseminated Encephalomyelitis in the Immune Cell Network
- ClinicalTrials.gov ID
- NCT06863974
- Acronym / sponsor ID
- HOT-BRAIN / 2024-A02732-45
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 16 Nov 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 7 Mar 2025 (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.
Acute disseminated encephalomyelitis (ADEM) is a neuroinflammatory disorder of the central nervous system, manifesting itself as impaired consciousness, even to the point of coma, and multifocal neurological deficits. ADEM is the most common encephalitis in children. Moreover, 50-65% of ADEM in children is associated with the presence of anti-MOG antibodies (MOGAD). In fact, ADEM is the most frequent clinical presentation of MOGAD in children, 50-75% before the age of 10. The risk of recurrence is higher in pediatric MOGAD of ADEM manifestation, up to 30%, compared to myelitis or optic neuritis. Multiphasic MOGAD are more frequently associated with sequelae in 50-69% of cases, versus 4-32% for monophasic forms. In ADEM, cognitive and epileptic sequelae predominate. The 2020 European consortium and the 2022 national diagnosis and care protocol recommend the introduction of disease-modifying therapies as early as the second attack of the disease, or in the event of distant sequelae, in order to limit relapses and sequelae. However, these treatments take several months to take effect.
There is currently no reliable predictive factor for MOGAD recurrence other than the persistence of an elevated blood anti-MOG antibody level (≥1:1280) at 1 year. The aim of this study is therefore to identify biomarkers associated with MOGAD recurrence from the first attack. To this end, we will study the transcriptome of circulating blood mononuclear cells by single-cell next-generation RNA sequencing in children with anti-MOGAD neuroinflammatory relapses. Anticipating the multiphasic trajectory of the disease would enable the introduction of early disease-modifying therapy to prevent recurrences and long-term sequelae. Furthermore, the discovery of a molecular and/or cellular signature would provide a better understanding of the pathophysiology of ADEM and MOGAD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective recruitment requires pre-inclusion because the characterization of antibodies allowing patients to be classified into these 3 groups is only done at a later stage.
| Arm | Type | Receives |
|---|---|---|
| ADEM non-MOGAD | Experimental | Other: Blood testNon-MOGAD ADEM control group of 5 patients with anti-MOG antibody-negative ADEM |
| ADEM MOGAD | Active comparator | Other: Blood testSingle-phase and multi-phase ADEM MOGAD units respectively |
| MOGAD non-ADEM | Experimental | Other: Blood testMOGAD non-ADEM central nervous system demyelinating neuroinflammatory control group (anti-MOG antibody-positive optic neuritis or myelitis) of 5 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Prospective recruitment Pre-inclusion criteria
- Age at inclusion between 1 and 18 years (included)
- First demyelinating event at inclusion, such as ADEM encephalitis, optic neuritis (NORB) or myelitis, or a combination of these conditions.
- Informed consent signed by patient's legal representative
- Patient affiliated to or benefiting from a social security scheme Inclusion criteria (confirmation of inclusion and follow-up in one of 3 groups)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood testDrawing blood to realize biomarkers of disease course of MOGAD-ADEM and pathophysiology of ADEM (and MOGAD) : cellular and molecular signatures, inflammatory signaling. | Other | ADEM MOGAD, ADEM non-MOGAD, MOGAD non-ADEM |
Primary outcome
Blood sample
Time frame: Inclusion, 6 months, 24 months
1 tube (approx. 5 mL) for children under 12 kg, 2 tubes (approx. 10 mL) for children between 12 kg and 20 kg, 4 tubes (approx. 20 mL) for children over 20 kg. Collected tubes are transferred to the investigator's Biological Resource Center (BRC) for sample preparation of the biocollection, if accepted in the consent form, and preparation of circulating blood mononuclear cells (PBMC).
Age
Time frame: Inclusion
Personal or family history of inflammatory or dysimmune disease
Time frame: Inclusion
Weight
Time frame: Inclusion, 6 months, 24 months
Weight (kg)
EDSS (Expanded Disability Status Scale)
Time frame: Inclusion, 6 months, 24 months
The neurological examination is divided into eight functional systems, 4 major (pyramidal, cerebellar, sensory, brainstem), 4 minor (sphincter, vision, mental and other). A numerical score of increasing severity (0 to 6 or 7) is given to each functional system (FS). The overall scale score is measured on a 20-level scale (0 to 10 per half-point). Up to level 3.5, the score obtained in each FS (Functional System) and the number of FS reached automatically determine the EDSS score. From 4 to 7, the definition of each level is also given by the walking disability (ability to walk without stopping, need for assistance).
Neurological episodes consistent with demyelinating relapse since previous visit
Time frame: 6 months, 24 months
Number, date, neurological symptoms including chronic fatigue unusual for an individual of the same age, diagnosis of demyelinating relapse, type, hospitalization, treatment with intravenous corticosteroid bolus.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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ADAM'S Prognostic Markers
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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.
Nail BENALLEGUE, DOCTOR principal investigator
University Hospital, Angers
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Acute Disseminated Encephalomyelitis and Encephalitis Autoimmune, run by University Hospital, Angers at 8 sites 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 23 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nail BENALLEGUE, DOCTOR (+33241354445, nail.benallegue@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sample (time frame: Inclusion, 6 months, 24 months). The study lists 6 primary outcomes in all. 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 27 Apr 2026.