Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS

This is a Phase 2b/3 multicenter, randomized, double‐blind, placebo‐controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN‐166 followed by an open‐label extension phase compared to matching placebo in subjects diagnosed with ALS. The study will consist of a screening phase (up to 30 days) followed by a double‐blind phase (12 months). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to one of two treatment groups: MN‐166 or matching placebo in a 1:1 ratio. Upon completion of the double‐blind phase, subjects will be given the option to continue to the Open‐label Extension Phase for a period of six months.