ALS: edaravone found safe, effective in well-defined group

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Takeaway

  • Edaravone (Radicava) slowed the decline in function during 24 wk in patients with early-stage definite or probable amyotrophic lateral sclerosis (ALS).

Why this matters

  • ALS is incurable and has limited treatment options.

Key results

  • Patients in the edaravone group had a smaller reduction in Revised ALS Functional Rating Scale (ALSFRS-R) score than counterparts in the placebo group (−5.01 vs −7.50; least-squares mean difference, 2.49; P=.0013).
  • The rate of treatment-emergent adverse events was high and identical in the 2 groups, at 84%.
  • Patients in the edaravone group had a lower rate of serious adverse events (16% vs 24%) and events leading to withdrawal (1% vs 6%).

Study design

  • A phase 3, randomized, doub...