Clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

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Current effective version

Adopted guideline

Reference numberEMA/531686/2015, Corr.1
Published21/12/2015
Effective from01/06/2016
KeywordsAmyotrophic lateral sclerosis (ALS), motor neuron disease
DescriptionThis document provides guidance on the clinical investigation of medicinal products for the treatment of myotrophic lateral sclerosis. It focuses on the design of studies for disease-modifying as well as symptomatic treatments, 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.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/06/2016


Published: 01/02/2016


Published: 01/08/2013


Published: 30/03/2012

Superseded documentAdopted guidelinePublished: 19/10/2000


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