Clinical Trial Issues

Several issues have arisen in the conduct of clinical trials in ALS, including the application of diagnostic criteria for patient enrollment, administration of clinical tests, and study design. The El Escorial World Federation of Neurology established diagnostic criteria in 1994 that were revised in 2000 to define more accurately the patient population selected for ALS clinical trials. Primary endpoint measures often used in clinical trials include: (1) muscle strength; (2) pulmonary function; (3) activities of daily living; and (4) survival. At least two different clinical instruments are being used to measure muscle strength, including maximum voluntary isometric contraction and manual muscle testing. Respiratory function is measured by maximum inspiratory pressure and forced vital capacity, both of which measure the strength of diaphragm muscle contractions.95 Two of the earliest rating scales for ALS were the Appel and Norris scales. The ALS functional rating scale (ALSFRS) is a favored primary endpoint owing to its short time for administration (5min), its correlation with physiological measures of disease progression, and relevance to the ability of a patient to function and perform tasks associated with daily living.

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