Edaravone and its clinical development for amyotrophic lateral sclerosis

Figures & data

Table 1. Comparison of the populations evaluated for efficacy (inclusion criteria).

^aEESP: patients with 2 points or better, on each of the individual items of the ALSFRS-R and %FVC ≥ 80% in the full analysis set (FAS). EESP was set in a post-hoc exploratory analysis of Study MCI186-16, and was prespecified before the code break of MCI186-17.

^b dpEESP2y: patients with definite or probable diagnosis based on the El Escorial revised Airlie House diagnostic criteria for ALS and within two years after the onset of ALS in the EESP.

^cD: definite ALS; P: probable ALS; PLS: probable ALS-laboratory-supported.

^d The Japan ALS severity classification score ranges from 1 to 5 as follows: (1) able to work or perform housework; (2) independent living but unable to work; (3) requiring assistance for eating, excretion or ambulation; (4) presence of respiratory insufficiency, difficulty in coughing out sputum or dysphagia; and (5) using a tracheostomy tube, tube feeding or tracheostomy positive pressure ventilation.