The European Medicines Agency has released a draft guideline on the clinical investigation of medicines for the treatment of amyotrophic lateral sclerosis (ALS) for a six-month public consultation.
The document focuses on the design of studies for medicines that have an impact on the course of the disease (disease-modifying treatments) as well as medicines that treat the symptoms of ALS. Guidance is provided on the choice of meaningful outcome parameters used in studies and the clinical relevance of functional tests of disability, including motor- and respiratory-function tests and their relationship to survival.
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