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Findings

What does this study add?

  • Atogepant 170 mg was rapidly absorbed following oral administration; median time to maximum concentration was ~2 hours and mean elimination half-life was ~10 hours.
  • Atogepant 170 mg was generally well tolerated with all reported adverse events (AE) being mild, except for one serious AE, a subarachnoid hemorrhage, unrelated to the study drug (bicycle accident).
  • The most frequent AEs reported (≥13% of participants) were fatigue, headache, decreased appetite, dizziness, nausea, back pain, vessel puncture-site pain, erythema, and pruritus.
  • Fatigue was the most common at 48%.
  • Two participants discontinued treatment with atogepant due to AEs.  
  • At the end of the study period, mean fold change in ALT from baseline was similar in both treatment groups (0.79 [95% CI, 0.70-0.89] with atogepant versus 0.99 [95% CI, 0.84-1.17] with placebo).
  • There were no ALT elevations three or more times the upper limit of normal at any post-dose time point.