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NCT05349006RecruitingPhase 3

Azathioprine in MOGAD

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

Source: ClinicalTrials.gov · Last updated 4 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
126 (estimated)
First submitted
15 Apr 2022
Start date
12 Dec 2023
Primary completion date
12 Dec 2026
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT05349006

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 126
  • From 12 Dec 2023 to the primary completion date, 12 Dec 2026
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any live vaccine in the past 3 months or planned during the RCT and RCT+6months
  • Necessary use of a xanthine oxidase inhibitor (Allopurinol, Oxipurinol, Thiopurinol, Febuxotat,…)
  • Necessary use of angiotensin-converting-enzyme inhibitor, cotrimoxazole, cimetidine and indometacine
  • Necessary use of any another immunosuppressive therapy, different than azathioprine, or steroids
  • Necessary use of cytotoxic therapy
  • Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy is use within 5 half-lives prior to baseline. Participation in a non- interventional study can be allowed as long as this participation does not interfere with this protocol or is not likely to affect the subject's ability to comply with the protocol.
  • For subjects coming back from strongyloidiasis endemic regions, a parasitology screening examination will be performed on faeces, and that appropriate treatment will be performed prior to administration of corticosteroids

Other illness

  • Hypersensitivity to azathioprine or steroids
  • Active infections or cancer (including tuberculosis, hepatitis, herpes and VZV)
  • Unable to complete an MRI (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media, or who lack adequate peripheral venous access)
  • Necessary use of any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation
  • Patients with Lesch Nyhan syndrome

Lab values

  • Seriously impaired bone marrow functions: Lymphocyte count \< 1000/ml and or Polynuclear neutrophil count \< 1500/ml
  • Seriously impaired hepatic functions: ALT and/or AST \> 3N
  • Seriously impaired renal functions: GFR \< 29 ml/min/1.73m²

Other

  • Psychosis not controlled by treatment
  • Thiopurine methyltransferase (TPMT) phenotype deficient or intermediate, with enzymatic activity \< 16 nmol/h/ml
  • Necessary use of an aminosalicylate derivates
  • Asian patients (probable mutation of the gene NUDT1)
  • Female subjects who have a positive a positive urinary or blood pregnancy test result, are pregnant or are currently breast feeding
  • Inability to comply with study requirements
  • Person under legal protection or deprived of liberty

Who the study is looking for

  • Age ≥ 18 years
  • First attack of documented acute demyelinating syndrome of the central nervous system, within the past 3 months, whatever the severity or the clinical phenotype
  • Tested positive for MOG-Ab, confirmed in a centralized lab (Lyon referral centre)
  • Ability of the subject to understand the purpose and risks of the study and provide signed and dated written informed consent.
  • Patients should be beneficiary 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Department of Neurology, CHU de Bordeaux - GH Pellegrin
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BordeauxFranceRecruiting
Department of Neurology, CHU of Lille, Hospital Roger Salengro
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LilleFranceRecruiting
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
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Department of Neurology University hospital Timone
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MarseilleFranceRecruiting
Department of Neurology Montpellier Universitary Hospital
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MontpellierFranceRecruiting
CHRU de Nancy Hôpital Central
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NancyFranceRecruiting
Department of Neurology, Hôpital Pasteur 2
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NiceFranceNot yet recruiting
Department of Neurology, Hôpital Caremeau
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NîmesFranceRecruiting
Department of Neurology. Hôpital A. Fondation Rothschild
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ParisFranceRecruiting
Department of Neurology APHP, Pitié Salpêtrière Hospital
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ParisFranceRecruiting
National Hospital of Vision (15-20)
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ParisFranceRecruiting
Department of Neurology, CHU de Rennes
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RennesFranceRecruiting
Department of Neurology, CHU de Rouen
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RouenFranceRecruiting
Department of Neurology, Hôpital g. Et r. Laennec
Coordinator of this site? Confirm its status
Saint-HerblainFranceRecruiting
Department of Neurology, Hôpital Hautepierre
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Department of Neurology, Toulouse Universitary Hospital
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ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.