Phase 3 Transverse Myelitis Trial, Recruiting NCT05349006 Sponsor: Hospices Civils de Lyon Condition: Transverse Myelitis
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Phase 3 Transverse Myelitis Trial, Recruiting

NCT05349006
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older
  • You have had your first episode of a condition where the protective coating around your brain or spinal cord nerves was attacked, and this happened within the last 3 months
  • Your blood test came back positive for MOG antibodies (a specific protein found in the blood), confirmed by a specialist laboratory in Lyon
  • You are able to understand what the study involves and are willing to sign a consent form agreeing to take part
  • You are covered by the French social security health system
  • If you are a woman who could become pregnant, you must use reliable contraception throughout the treatment and for at least 3 months after finishing treatment

Who may not be able to join:

  • You have a known allergy or bad reaction to azathioprine (an immune-lowering medicine) or steroids
  • You currently have an active infection (such as tuberculosis, hepatitis, herpes, or chickenpox-related virus) or an active cancer
  • You have a mental health condition involving psychosis that is not controlled with medication
  • Your bone marrow is not working well enough, shown by very low levels of certain blood cells (confirm with trial site)
  • Your liver is not working well enough, shown by high levels of certain liver enzymes in your blood (confirm with trial site)
  • Your kidneys are not working well enough, based on a measure of how well they filter your blood (confirm with trial site)
  • You have received a live vaccine in the past 3 months, or plan to receive one during the trial or for 6 months after the trial ends
  • You have a naturally low level of a specific enzyme called TPMT, which helps your body process certain medicines (confirm with trial site)
  • You are unable to have an MRI scan — for example, because you have a pacemaker, severe fear of enclosed spaces, an allergy to the contrast dye used in MRI, or poor vein access
  • You need to regularly take certain medicines that could interact with the trial treatment, including allopurinol or similar drugs, certain blood pressure medicines (ACE inhibitors), cotrimoxazole, cimetidine, or indometacin (confirm with trial site)
  • You need to take a type of medicine called aminosalicylates (used for conditions like Crohn's disease or colitis)
  • You are currently taking any other immune-suppressing medicine (other than the ones used in this trial) or any cancer-killing (cytotoxic) therapy
  • You are currently taking part in another clinical trial involving an experimental or approved treatment
  • You have recently travelled to or lived in an area where a parasitic infection called strongyloidiasis is common, and have not been tested and treated for it beforehand
  • You have a rare genetic condition called Lesch-Nyhan syndrome
  • You are of Asian background, due to a genetic variation that may affect how your body handles the trial medicine (confirm with trial site)
  • You are pregnant, breastfeeding, or have a positive pregnancy test
  • You are not able to follow the study requirements
  • You are under legal guardianship or currently have restrictions on your personal freedom

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Romain MARIGNIER, MD PhD, Hospices Civils de Lyon

Phone: +334 72 35 75 22

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
12 December 2023
Est. completion
12 December 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Time to first relapse (in days), comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov