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New treatment option for Acute Disseminated Encephalomyelitis
Official title High-throughput Omic Technology for Identification of Biomarkers of Relapsing Acute Disseminated Encephalomyelitis in Immune Cell Network
ClinicalTrials.gov ID: NCT06863974
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Prospective recruitment Pre- 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 (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...
See the full eligibility criteria
- Prospective recruitment Pre- 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 (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...
- 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 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...
- 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...
- Informed consent signed by patient's legal representative
- Patient affiliated to or benefiting from a social security scheme specific to the 3 study 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...
- 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-(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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Brest, France
- Le Kremlin-Bicêtre, France
- Montpellier, France
- Nantes, France
- Paris, France
- Rennes, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Brest, France; Le Kremlin-Bicêtre, France; Montpellier, France; Nantes, France; Paris, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.