Harmonized standard operating procedures for administering the ALS functional rating scale-revised

Abstract

The ALS Functional Rating Scale-Revised is the most commonly used primary outcome measure in current ALS clinical trials. While rigorous training and certification is generally recognized as critical to reliable performance, differences have existed between training in the two groups responsible for most training in ALS outcome measures. We present a harmonized standard operating procedure which is intended to further reduce response variability by the use of identical training in North America and Europe.

Keywords:

• Clinical trial
• ALSFRS-R
• training

Declaration of interest

JM Shefner: has received personal compensation from: Amylyx; Cytokinetics; Denali; GSK; Mitsubishi Tanabe Pharma America; Neurosense; Orthogonal; RRD; Acurastem; Revalasio; Apellis; Swanbio; Novartis; Sanofi. He has received research funding from: AB Sciences; Acorda Therapeutics; Alector; Amylyx; Biogen; Cytokinetics Incorporated; Ionis; Mitsubishi Tanabe Pharma America; Quralis; PTC; Sanofi; Wave; Myolex.

T Bunte: has nothing to declare.

G Kittle: has nothing to declare.

A Genge: has received personal compensation from Quralis, Amylyx, MTPA, Mitsubishi Canada, Alexion, Avenue, AL-S Pharma, Lilly, Biogen, Regeneron, UCB, Fulcrum, Vertex, Calico.

LH van den Berg: has received personal compensation from Sanofi, Biogen, Amylyx, Ferrer, Corcept, QurAlis, Cytokinetics, Argenx, VectorY. He has participated as principal investigator to clinical trials on ALS sponsored by Biogen, Cytokinetics, Ferrer, Amylyx, Wave Life Sciences, Corcept therapeutics, Sanofi, AB Science, IONIS Pharmaceuticals, Apellis Pharmaceuticals, Alexion Pharmaceuticals, Orphazyme, Orion Pharma.