NCT04944784

Who might be able to join this trial:

• You are between 18 and 80 years old (inclusive)
• You have been diagnosed with familial or sporadic ALS, meeting certain diagnostic standards set by a global neurology organization (confirm with trial site if unsure which category applies to you)
• Your first ALS symptom — such as weakness in your arms, legs, speech, swallowing, or breathing — started no more than 24 months before your screening appointment
• Your ALS Function Rating Scale score (a measure of how ALS is affecting daily tasks) is 44 or below at screening — if it is 45 or higher, you may be able to be rescreened about 60 days later
• Your lung function (measured by a breathing test called FVC) is at least 65% of what would be expected for someone your age, height, sex, and ethnicity
• You have either been taking the ALS medication riluzole for at least 30 days, or you have not taken it for at least 30 days before screening
• You have either completed at least 2 treatment cycles of the ALS medication edaravone, or you have not taken it for at least 30 days before screening
• You are able to swallow whole tablets

Who may not be able to join:

• Your kidneys are not functioning well enough, based on a specific blood test result (confirm with trial site)
• A urine test shows too much protein, which can be a sign of kidney issues
• Your liver enzyme levels (ALT or AST) are three or more times higher than the normal range
• Your bilirubin levels (a measure of liver function) are above the normal range
• You have cognitive (thinking or memory) problems — whether related to ALS or another cause — that would make it difficult to understand the study or give your consent
• You have another significant neurological condition that could make it harder to assess your ALS symptoms or progression
• You currently have a tracheostomy (a surgical opening in the throat to help with breathing)

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