The initial phase 3 study of edaravone did not show a significant difference in the decline in the

ALS-FRS-R scores in treated patients compared to placebo.. However, a post-hoc analysis and a subsequent phase-3 study revealed that patients in the early stages of ALS with mild symptoms and preserved respiratory function did show a slower progression than did the full study population.  The FDA approval of the drug was based on this small study in a population that was followed over a 24 week period, leaving very little time for recordable adverse events to manifest. We hypothesize that although administration of edaravone in the early stages of ALS may be beneficial, there is a more rapid respiratory decline in patients that continue to receive edaravone once respiratory function begins to decline. 

This study will involve a restrospective review of ALS-FRS-R scores and pulmonary function tests in ALS cases seen at the Boston VAMC since 2016.  Patients with definite/probable ALS will be included. Patients with tracheostomy or other identified cause for respiratory decline will be excluded. ALS-FRS-R scores and pulmonary function tests will be compared using t-test (with p<0.05) in patients receiving edaravone compared to patients not receiving the drug.

Edaravone should be used with caution in ALS patients once respiratory decline begins. 

(Data collection and analysis is ongoing and is anticipated to be complete by time of meeting).