ALS Clinical Trials Review: 20 Years of Failure. Are We Any Closer to Registering a New Treatment?

Of the 31 studies that included pre-specified efficacy measures as the secondary endpoint(s) and recruited ≥100 patients, 26 studies did not reach statistical significance in any of the secondary endpoints in the pre-defined analyses (including studies that did not report P -values).

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The other two RCTs with edaravone in ALS, which recruited patients with a wider inclusion criteria ( Abe et al., 2014 ), and patients with more advanced disease ( Tanaka et al., 2016b ) have failed to reach statistical significance on the primary endpoint.

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