Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial

Recruiting Phase 3 Interventional Study
Acute Demyelinating Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
86 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
Among all non viral encephalitis, myelin oligodendrocytes glycoprotein antibody associated diseases (MOGAD) are the second most frequent diagnosis in children. Risk of relapses varies according to studied cohorts and cognitive and academic difficulties are more and more detected in children without knowing if these sequelae are related to the first attack or relapses. The hypothesis is that earlie…
Trial Locations
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Eligibility Criteria
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, rhombe…
Contacts

Kumaran DEIVA, phD

0145213112

kumaran.deiva@aphp.fr

CONTACT

Domitille MOLINARI

0145217138

domitille.molinari@aphp.fr

CONTACT