Atogepant bests placebo for migraine control

  • Goadsby PJ & al.
  • Lancet Neurol
  • 1 Sep 2020

  • curated by Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • Patients with migraine who received oral atogepant for 12 weeks had significantly fewer migraine days per month than those who received a placebo.

Why this matters

  • Atogepant is delivered orally, offering a potential advantage over similar drugs currently available only by subcutaneous or intravenous injection.

Study design

  • Double-blind, randomized, multicenter, phase 2b/3 trial.
  • 825 patients with a history of migraine and 4-14 migraine days per month received placebo (n=186) or atogepant 10 mg once daily (n=93), 30 mg once daily (n=183), 60 mg once daily (n=186), 30 mg twice daily (n=86), or 60 mg twice daily (n=91).
  • Funding: Allergan (before its acquisition by AbbVie).

Key results

  • Significantly greater decreases in mean monthly migraine days in all atogepant groups compared with those receiving placebo (P=.039).
  • All atogepant dosages were associated with significantly greater decreases in mean monthly headache days than placebo (P=.039).
  • Significantly more patients reported ≥50% reduction in monthly migraine days in the 30-mg twice-daily (OR, 1.8; P=.034) and 60-mg twice-daily (OR, 2.0; P=.0097) groups compared with placebo.
  • Significantly greater reduction in acute medication use in patients in the 30-mg twice-daily (−1.4 days; P=.034) and the 60-mg twice-daily group (−1.2; P=.0097) groups compared with placebo.
  • Most common treatment-related adverse event was nausea.

Limitations

  • No long-term data.