EMA: Draft guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

This document replaces and updates the previous points to consider on amyotrophic lateral sclerosis and focuses on the design of studies for disease-modifying as well as symptomatic treatments in this therapeutic area, the choice of meaningful outcome parameters and the clinical relevance of functional tests of disability, including motor and respiratory functions and their relationship to survival.