DAZALS: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Of Dazucorilant, A Selective Glucocorticoid Receptor Modulator, In Amyotrophic Lateral Sclerosis

Summary  

  • No impact to ALSFRS-R: DAZALS did not achieve its primary endpoint of slowing functional decline as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) scale
  • Survival improved by dazucorilant 300 mg: Secondary and exploratory endpoints showed improvement in overall survival for patients who received dazucorilant 300 mg, including those treated for >24 weeks
  • Tolerability: Dazucorilant-treated patients discontinued at higher rates than placebo-treated patients due to abdominal pain, which occurred in the first 3–5 weeks. Abdominal pain resolved following treatment interruption and with time in patients who continued treatment
  • No additional serious or severe AEs: Dazucorilant-treated patients showed similar rates of serious and severe adverse events (AEs) compared to placebo-treated patients

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