Phase 2 Transverse Myelitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with your first-ever episode of optic neuritis, confirmed by an MRI scan
• Your vision changes (such as blurred vision or reduced sharpness) began within the last 10 days before joining the study — if both eyes are affected, this counts from when the first eye was affected
• Your vision in the more affected eye is 20/60 or worse, even with glasses or contacts
• You are willing and able to follow all study procedures for the full duration of the trial
• You have signed and dated a consent form agreeing to take part
• If you can become pregnant: you have had a negative pregnancy test and agree to use effective birth control during the study and for 8 weeks after the last treatment dose
• If you can father a child: you agree to use condoms or other effective contraception during the study

Who may not be able to join:

• You are currently pregnant or breastfeeding
• You have a known allergy or bad reaction to any of the study medications (efgartigimod, methylprednisolone, prednisone, or gadolinium, which is used in MRI scans)
• You had a pre-existing eye nerve condition (optic neuropathy) before this current episode
• Your optic neuritis appears to be caused by a condition other than MS, NMOSD, or MOGAD
• You are currently taking, or plan to take within 3 weeks, medications that suppress or modify your immune system
• You have already been diagnosed with MS, NMOSD, or MOGAD before this current episode
• You have another significant eye condition (such as glaucoma, cataracts, or retinal problems) that was already affecting your vision before this episode — note that being born with colour blindness does not exclude you
• There is another explanation found for your vision changes during an eye examination
• You have taken part in another clinical trial involving an experimental treatment within the past 2 months
• You cannot have an MRI scan or plasma exchange (a blood-filtering procedure used in the study)
• You have already received more than 3 days of high-dose steroids for this current episode of optic neuritis before being assigned to a treatment group in the study
• You have HIV or a condition called common variable immunodeficiency (a disorder affecting the immune system)
• You have a history of cancer, unless it has been fully treated with no signs of return for at least 1 year — some skin cancers and certain early-stage cancers may still be eligible (confirm with trial site)
• You have a significant ongoing bacterial, viral, or fungal infection that is not well controlled
• You have had major surgery within the past month, or are planning surgery during the study
• You have any other condition or circumstance that the study doctor believes could put you at risk or affect the study results (confirm with trial site)

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