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RECRUITING
NCT05349006
PHASE3

Azathioprine in MOGAD

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2023-12-12

Completion Date

2029-12-12

Last Updated

2025-02-04

Healthy Volunteers

No

Interventions

DRUG

Azathioprine

Dose related to weigh (100 mg for weight ≤ 50 kg and 150 mg for weight \> 50 kg) = 2 to 4 50mg oral caps, daily, during all the study period

OTHER

Placebo

Dose related to weigh (100 mg for weight ≤ 50 kg and 150 mg for weight \> 50 kg) = 2 to 4 50mg oral caps, daily, during all the study period

Locations (17)

Department of Neurology, CHU de Bordeaux - GH Pellegrin

Bordeaux, France

Department of Neurology, CHU of Lille, Hospital Roger Salengro

Lille, France

Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer

Lyon, France

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

Department of Neurology University hospital Timone

Marseille, France

Department of Neurology Montpellier Universitary Hospital

Montpellier, France

CHRU de Nancy Hôpital Central

Nancy, France

Department of Neurology, Hôpital Pasteur 2

Nice, France

Department of Neurology, Hôpital Caremeau

Nîmes, France

National Hospital of Vision (15-20)

Paris, France

Department of Neurology APHP, Pitié Salpêtrière Hospital

Paris, France

Department of Neurology. Hôpital A. Fondation Rothschild

Paris, France

Department of Neurology, CHU de Rennes

Rennes, France

Department of Neurology, CHU de Rouen

Rouen, France

Department of Neurology, Hôpital g. Et r. Laennec

Saint-Herblain, France

Department of Neurology, Hôpital Hautepierre

Strasbourg, France

Department of Neurology, Toulouse Universitary Hospital

Toulouse, France