Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

To be considered for this study, you need to be at least 18 years old and have a definite or very likely diagnosis of ALS. It's important that your ALS symptoms started less than 24 months ago. If you're already taking other ALS medications like riluzole or edaravone, these should have been at a steady dose for a set period before you join.

There are also some reasons why you might not be able to join. For example, if you need a breathing machine (tracheostomy or permanent assisted ventilation) or if your breathing capacity is very low (less than 55% of what's expected). You also can't have certain allergies, severe liver or kidney problems, or currently be pregnant or breastfeeding. The research team will do medical checks to make sure it's safe for you to take part.

If you decide to take part, you'll be assigned either to receive the study drug (AMX0035) or a dummy drug (placebo). You won't know which one you're getting. You'll need to attend regular clinic visits over a period of 48 weeks. During these visits, the study team will carry out various checks, including assessing your physical abilities, breathing function, and taking blood samples. You'll also be asked about your quality of life. You'll continue taking the study medication for the full 48 weeks. After this, there might be some follow-up checks. Women who can become pregnant and men will need to use effective birth control during the study and for three months after their last dose.