Condition: Central Nervous System Inflammation · MOG-IgG Associated Disease · Sponsor: Hospices Civils de Lyon
MOG-IgG associated disease (MOGAD) is a rare inflammatory disease of the central nervous system recently described. Initially reported as monophasic, data from incident cohorts suggests that around 50% of adult patients with MOG-Ab may relapse within the first two years of the disease, with most of relapses occurring early after disease onset. No randomized controlled trial has ever been performed and therapeutic guidelines for this disease remain unclear especially after a single event. In short-sized and mainly retrospective study, azathioprine, an immunosuppressant drug, have showed promising results on preventing the risk of relapse in MOGAD patients. The hypothesis is that the initiation of a treatment after a first attack of MOGAD should prevent further relapse and disability accrual. The investigators propose herein the first randomized controlled trial in MOGAD, to evaluate the efficacy of azathioprine to prevent relapses, after a first attack, in a placebo double-blinded design.
This description comes directly from the study's public registry record.
Romain MARIGNIER, MD PhD · +334 72 35 75 22 · romain.marignier@chu-lyon.fr
Lakhdar BENYAHYA, project manager · +334 72 68 49 07 · lakhdar.benyahya@chu-lyon.fr
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| Department of Neurology, CHU de Bordeaux - GH Pellegrin | Bordeaux, France | Recruiting |
| Department of Neurology, CHU of Lille, Hospital Roger Salengro | Lille, France | Recruiting |
| Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer | Lyon, France | Recruiting |
| Service de Neurologie sclérose en plaques, pathologies de la myéline et neuro-inflammation - Centre de référence des maladies inflammatoires rares du cerveau et de la moelle (MIRCEM) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon | Lyon, France | Recruiting |
| Department of Neurology University hospital Timone | Marseille, France | Recruiting |
| Department of Neurology Montpellier Universitary Hospital | Montpellier, France | Recruiting |
| CHRU de Nancy Hôpital Central | Nancy, France | Recruiting |
| Department of Neurology, Hôpital Pasteur 2 | Nice, France | Not Yet Recruiting |
| Department of Neurology, Hôpital Caremeau | Nîmes, France | Recruiting |
| National Hospital of Vision (15-20) | Paris, France | Recruiting |
| Department of Neurology APHP, Pitié Salpêtrière Hospital | Paris, France | Recruiting |
| Department of Neurology. Hôpital A. Fondation Rothschild | Paris, France | Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05349006