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Azathioprine in MOGAD

Study acronym: MOGwAI
StatusRecruiting
PhasePhase 3
Started2023-12-12
View on ClinicalTrials.gov ↗

Amendment history

2025-01-31
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-01-01→2026-12-12
Completion date2029-01-01→2029-12-12
Start dateestimated 2023-01-01→confirmed 2023-12-12
Study sites15→17
Eligibility criteria+986 characters
[...] ry of health care coverage under the social security system Female patients of childbearing potential should have effective contraception throughout the course of treatment and for at least three months after stopping treatment. Exclusion Criteria: Hypersensitivity to azathioprine or steroids Active infections or cancer (including tuberculosis, hepatitis, herpes and VZV) Psychosis not controlled by treatment Seriously impaired hepatic or bone marrow functions: Lymphocyte count < 1000/ml and or Polynuclear neutrophil count < 1500/ml Seriously impaired hepatic functions: ALT and/or AST > 3N Seri [...] [...]
2022-11-24
Study Status v1
Primary completion date2025-10-01→2026-01-01
Completion date2028-10-01→2029-01-01
Start date2022-10-01→2023-01-01
2022-04-21
Original filing
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.
Trial Details
NCT Number NCT05349006
Lead Sponsor Hospices Civils de Lyon
Conditions Central Nervous System Inflammation, MOG-IgG Associated Disease
Enrollment 126 participants
Start Date 2023-12-12
Primary Completion 2026-12-12 (estimated)
Study Completion 2029-12-12 (estimated)
Updated on ClinicalTrials.gov 2025-02-04