This study’s primary aim was to identify assessment measures that are more sensitive to disease progression in participants with ALS type Motor Neurone Disease and put them in rank order over 6 and 12 months. The secondary objectives were: To repeat each of these measures to demonstrate they are accurate and reliable; To determine correlations between these measures and changes at 6 and 12 months and standard measures at 18 and 24 months; to obtain biological samples in order to identify if molecular changes are reflected in clinical measures and to further understand previously identified molecular biomarkers of disease progression for incorporation into future clinical studies. A biomarker is a biological indicator of disease, a measurable characteristic which may be used as an indicator of a condition, for example DNA extracted from blood samples. The study ran over two years and included seven study visits and four telephone calls in the first year and three telephone calls in the second year.
This study was sponsored by Biogen and further information can be found via: https://clinicaltrials.gov/ct2/show/NCT02611674