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Abstract Details

Retrospective review of respiratory function in the Amyotrophic Lateral Sclerosis(ALS) veteran population with and without Edaravone therapy.
Neuromuscular and Clinical Neurophysiology (EMG)
S54 - Motor Neuron Disease (4:58 PM-5:09 PM)
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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. 

The objective of this study is to determine if there is more rapid respiratory decline in patients receiving edaravone therapy compared to patients not receiving edaravone in a veteran population. 

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.

 

Preliminary review of a subset of this population show there is a more rapid decline in respiratory function in patients receiving edaravone (full dataset review is ongoing). 

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). 

Authors/Disclosures

PRESENTER
No disclosure on file
Mohammad Salajegheh, MD, FAAN (VA Boston Healthcare System) Dr. Salajegheh has received personal compensation in the range of $100,000-$499,999 for serving as a Employee with US Department of Veterans Affairs.
Nikita James No disclosure on file