Transverse Myelitis Trial, Recruiting

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

Who might be able to join this trial:

For people with an inflammatory brain or spinal cord disease (IIDD group):

• People aged 18 to 65 years old (inclusive) who are able to understand the study, agree to take part, and allow their health information to be used in line with privacy laws
• Both men and women are welcome, provided they agree to use contraception throughout the study and for at least 30 days after the last dose, and agree not to donate sperm or eggs during this time
• People diagnosed with Multiple Sclerosis (MS) meeting specific 2017 diagnostic criteria
• People diagnosed with a condition called AQP4-positive Neuromyelitis Optica Spectrum Disorder (NMOSD), confirmed by a positive AQP4 antibody test and meeting 2015 international diagnostic criteria
• People diagnosed with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), confirmed by a specific antibody test and meeting 2023 international diagnostic criteria
• People diagnosed with Acute Disseminated Encephalomyelitis (ADEM), meeting 2013 international diagnostic criteria, with symptoms affecting multiple areas of the nervous system and including changes in behaviour or consciousness not explained by fever
• People whose disability level is at or below a score of 4 on a standard neurological scale (EDSS) at the start of the study
• People whose neurological condition has been stable for at least 30 days before the study begins

For healthy volunteers:

• People aged 18 years or older who are in good health with no underlying medical conditions

Who may not be able to join:

• People with a significant history of serious heart, hormonal, blood, liver, immune system, infectious, metabolic, kidney, lung, neurological, skin, or psychiatric conditions, as determined by the treating doctor
• People who have an untreated teratoma or thymoma (types of tumours) at the start of the study
• People whose symptoms are caused by other conditions such as brain infections, metabolic problems, epilepsy, mitochondrial disease, or certain rare disorders
• People who have had herpes simplex encephalitis (a type of brain infection) within the past 24 weeks
• People who have had surgery within 4 weeks before the study begins, except for minor procedures done under local anaesthetic on an outpatient basis (such as mole removal or wisdom tooth extraction), or removal of a thymoma or teratoma
• People who have planned surgery during the study (except minor procedures)
• People with a history of severe allergic reactions, or any allergy that the treating doctor considers may be made worse by the study treatment
• People with a current or past history of cancer, including blood cancers and solid tumours — exceptions may apply for certain skin cancers fully removed and considered cured at least 12 months before the study, and for cancers in remission for more than 5 years (confirm with trial site)
• People with a history of certain bowel or stomach conditions, including inflammatory bowel disease, irritable bowel syndrome, or significant gastrointestinal surgery (except appendix or gallbladder removal more than 6 months before screening)
• People who have had ongoing or significant digestive symptoms (such as nausea, diarrhoea, or constipation) within 90 days before screening, or who have recently started or changed treatment for such symptoms
• People with a history of a bowel condition called diverticulitis, or other significant bowel problems, due to a risk of serious complications
• People who have donated blood, plasma, or platelets within 90 days before screening
• People with active thoughts of suicide within the past 6 months, or a history of a suicide attempt within the past 3 years
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 3 months after the last dose — women who could become pregnant must have a negative pregnancy test before joining
• People whose mental or physical condition would make it difficult to assess the safety or effectiveness of the treatment
• People with blood pressure that is too high (above 150 mmHg systolic) or too low (below 90 mmHg systolic) after sitting quietly for 5 minutes, confirmed on repeated measurement
• People with certain heart conditions, including specific types of heart rhythm problems, unstable chest pain, heart failure, recent heart attack, or an abnormal ECG reading, within 3 months before screening
• People who have planned non-urgent procedures or surgeries at any point after signing the consent form
• People with conditions that may affect how the study treatment is absorbed, such as having had the stomach removed
• People with a history of allergic reaction to heparin, or a condition called heparin-induced thrombocytopenia (a reaction to heparin that affects blood platelets)
• People with HIV, or a positive HIV test at screening
• People with active hepatitis C infection (confirmed by both a positive antibody test and detectable virus in the blood)
• People with active hepatitis B infection (confirmed by specific blood markers)
• People who have had a serious, repeated, or long-lasting infection (such as pneumonia or blood infection) within 90 days before the study begins
• People with a history of tuberculosis (TB) or a positive test for latent (inactive) TB
• People who have had symptoms of a bacterial, fungal, or viral infection (including a common cold) within 28 days before the study begins — those with a localised fungal infection may be able to re-screen after successful treatment (confirm with trial site)
• People who have needed hospital admission or intravenous (IV) antibiotics for an infection within 4 weeks before the start of the study
• People who have received a live or live-attenuated vaccine within 28 days before the study begins, or who plan to receive one during the study
• People who have contraindications to all of the following treatments: rituximab, intravenous immunoglobulin, high-dose corticosteroids, and IV cyclophosphamide
• People who have previously received certain treatments including total lymphoid irradiation, cladribine, T-cell vaccination, whole body irradiation, or a stem cell transplant at any point in their history
• People with abnormal blood test results at screening, including low white blood cell, neutrophil, lymphocyte, or platelet counts, or abnormal liver or kidney function results
• People with abnormal urine test results at screening showing certain kidney-related markers above accepted levels
• People who have previously taken part in this same study
• People who have donated blood within 90 days, plasma within 1 week, or platelets within 6 weeks before screening
• People with a history of alcohol or drug misuse in the past year, as assessed by the treating doctor
• People who are currently taking part in another clinical trial, or who have done so within 90 days before screening
• People with a clinically significant history of suicidal thoughts or behaviours in the past 12 months, as measured by a specific assessment scale at screening
• People who are unwilling or unable to follow the study requirements
• People with significant hearing or vision loss, language barriers, fear of confined spaces (claustrophobia), or other difficulties that would prevent them from completing psychological assessments or MRI scans
• People the treating doctor or study sponsor considers unsuitable for any other reason

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