Can starting treatment right after a first attack prevent relapses in children?
NCT ID NCT05545384
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether giving children azathioprine or rituximab immediately after their first MOGAD attack reduces relapses and long-term disability compared with waiting until a second attack. The study enrolls children aged 6 to 17 who have had a first inflammatory event linked to MOG antibodies. Researchers will compare the annualized relapse rate over 24 months between the immediate and delayed treatment groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- azathioprine or rituximab
- What this could lead to
- If starting treatment right after the first attack works, it could reduce the number of relapses and lower the risk of lasting disability in children with MOGAD.
- What could go wrong
- The trial is still testing this approach, and it is not yet known if immediate treatment is better than waiting. Both drugs carry risks like infection or liver problems, and the results may not apply to all children.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Children \< 18 years old and ≥ 6 years old at baseline * Children weight ≥ 20 kg * All ADS with confirmed anti-MOG-Abs at onset including any acute neurologic symptom with a duration of more than 24H of inflammatory causes (including optic neuritis, transverse myelitis, rhombencephalitis, ADEM, NMOSD) Without any previous treatment other than steroids * Informed consent signed by both parents and the child * Expanded Disability Status Scale (EDSS) \< 5.5 * Affiliated to French social security regime Exclusion Criteria: * Current infection with SARS-COV2 (positive PCR) * Any prior allergy to azathioprine or rituximab with hypersensitivity to active substances, murine proteins or to any of the excipients. * Any prior history of uncontrolled cancer during the last 2 years * Uncontrolled infections (Hepatitis B, C and HIV) * Any prior history of cardiac dysfunction and/or hypertension * Any progressive or non-relapsing form demyelinating diseases * Any previous treatment with natalizumab, daclizumab, fingolimod, methotrexate, cyclosporine, mycophenolate mofetil, rituximab in the last 6 months, or determined by the treating physician to have residual immune suppression from these or other immunosuppressive treatments * CD4+, CD8+, or CD19+ absolute cell count, wbc, neutrophiles in blood at screening below lower limits of normal (LLN) * Creatinine\>30µmol/L * Platelets \<70 000mm3 * Haemoglobin \< 8g/dL * Acute renal insufficiency (clearance \< 30 ml/min) * Prior documented history of hemostase perturbation (TP and/or TCA more than twice of the witnesse's TP and/or TCA) * Prior documented history of increased liver enzyme level (ASAT and/or ALAT) \> 2N. * TP \<70% * Total bilirubin \> 2N * Any patient with allopurinol treatment and immunosupressive treatment with concomitant use of xanthine oxidase inhibitors (e.g. allopurinol, oxipurinol/thiopurinol, febuxostat) * Patients with two inactive TPMT or NUDT15 alleles (homozygous deficient or double heterozygote) * Pregnancy or lactating woman or wish for future pregnancy * Refusal to have a highly effective contraception during traitment and for one year (12 months) after the end of the experimental treatment * participation to another interventional study within 5 half-lives prior to baseline. * Active, severe infections (including tuberculosis, HBV and HCV, HIV, herpes, VZV, EBV and CMV) * Psychosis not controlled by treatment * Patients with Lesch Nyhan syndrome * Pheochromocytoma * Scleroderma * Untreated peptic ulcer * Myasthenia gravis * Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHRU Lille
NOT_YET_RECRUITINGLille, France
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CHU Besançon
NOT_YET_RECRUITINGBesançon, France
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CHU Bordeaux
NOT_YET_RECRUITINGBordeaux, France
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CHU Brest
NOT_YET_RECRUITINGBrest, France
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CHU Monptellier
NOT_YET_RECRUITINGMontpellier, France
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CHU Strasbourg
NOT_YET_RECRUITINGStrasbourg, France
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CHU Toulouse Purpan
NOT_YET_RECRUITINGToulouse, France
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HCL de Bron
NOT_YET_RECRUITINGBron, France
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Hôpital Bicêtre
RECRUITINGLe Kremlin-Bicêtre, 94270, France
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