Phase 1 Motor Neurone Disease 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:

• You are between 18 and 70 years old
• You have been diagnosed with ALS (either familial or sporadic) according to recognised international diagnostic standards, confirmed as probable or definite
• If you are already taking riluzole (Rilutek®) and/or edaravone (Radicava®), you may continue, as long as your dose has been stable for more than one month
• It has been more than two weeks since any major surgery or since you finished participating in another research trial
• Any side effects from previous treatments have largely resolved to a mild level
• Your kidney function blood test (creatinine) result is within an acceptable range (≤ 2.0 mg/dL)
• Your liver function blood test results (AST and ALT) are within an acceptable range (less than 3 times the upper limit of normal)
• Your bilirubin (a liver marker) is within an acceptable range (confirm with trial site if you have Gilbert's disease)
• Your lung breathing capacity test result is above 70% of what would be expected for a person of your age and size
• You have no history of unusual or abnormal bleeding
• You are willing and able to give informed consent, understanding you can withdraw at any time without it affecting your future medical care

Who may not be able to join:

• You currently have an infection that is not under control
• You have high blood pressure that cannot be controlled even with three or more medications
• You have had a blood clot in your lungs (pulmonary embolism) within the past 6 months
• You have had a significant heart problem in the past 6 months, such as a heart attack, severe heart failure, uncontrolled chest pain, or serious irregular heart rhythm
• You have had heart bypass surgery or a procedure to open blocked arteries — this will be reviewed individually by a heart specialist (confirm with trial site)
• You have tested positive for HIV, hepatitis B, or hepatitis C
• You are currently pregnant or breastfeeding
• You are capable of becoming pregnant, or your partner is capable of becoming pregnant, and you are unwilling to use contraception during the trial
• You are currently taking part in another interventional clinical trial
• You have received another experimental drug, biological treatment, or device within the past 30 days (or longer, depending on the treatment)
• You have previously received gene therapy or cell therapy for ALS
• You have a significant history of cancer, serious liver or kidney disease, or another serious uncontrolled medical condition
• You currently have a feeding tube in place
• You are currently taking certain antipsychotic medications, most antiepileptic drugs (except benzodiazepines, gabapentin, or pregabalin), or certain heart rhythm medications (confirm with trial site)
• The trial doctor considers you to be at significant risk of suicide
• The trial doctor considers you unsuitable for any other reason

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