A randomised, double-blind, placebo-controlled, multicentre phase III trial evaluating the safety and efficacy of AMX0035 versus placebo for 48 weeks of treatment in adult patients with amyotrophic lateral sclerosis (ALS).

AMX0035 consists of a combination of two substances, phenyl butyrate and taurursodiol. It is being investigated whether the combination of these two substances can inhibit the disease.

You have a 60% chance of getting AMX0035 and a 40% chance of getting placebo.

The study drug comes in a sachet to be dissolved in water, you will start with 1 sachet per day. After 14-21 days, this can be increased to 2 sachets a day, this only after contacting the study centre by telephone.

The study lasts about 1 year, after that period you can further participate in an open label study.