More evidence of ubrogepant effectiveness in migraine pain

  • Dodick DW & al.
  • N Engl J Med
  • 05/12/2019

  • Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • Patients who received ubrogepant for treatment of migraine had greater pain relief and decrease in the most bothersome migraine symptoms at 2 hours than those who received a placebo.

Why this matters

  • This study confirms earlier research that found ubrogepant to be effective at treating acute migraine.  

Study design

  • This randomized, double-blind, parallel-group trial evaluated the efficacy, safety, and side-effect profile of ubrogepant in patients with a history of migraine (≥1 year).
  • Treatment received: placebo (n=456), 50-mg ubrogepant (n=423), or 100-mg ubrogepant (n=448).
  • Funding: Allergan.

Key results

  • The number of participants with freedom from migraine pain at 2 hours:
    • placebo group, 11.8%;
    • 50-mg ubrogepant group, 19.2% (vs placebo; OR, 1.83; Padjusted=.002); and
    • 100-mg ubrogepant group, 21.2% (vs placebo; OR, 2.04; Padjusted<.001>
  • Absence of the most bothersome symptom at 2 hours:
    • placebo group, 27.8%;
    • 50-mg ubrogepant group, 38.6% (vs placebo; OR, 1.70; Padjusted=.002); and
    • 100-mg ubrogepant group, 37.7% (vs placebo; OR, 1.63; Padjusted=.002). 
  • Any adverse events reported:
    • placebo group, 12.8%;
    • 50-mg ubrogepant group, 9.4%; and
    • 100-mg ubrogepant group, 16.3%.
  • Most common adverse events reported within 48 hours were nausea, somnolence, and dry mouth.

Limitations

  • Limited generalizability.

Coauthored by Chitra Ravi, MPharm