Ubrogepant efficacious for acute migraine

  • Lipton RB & al.
  • JAMA
  • 19/11/2019

  • Susan London
  • Clinical Essentials
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Takeaway

  • Ubrogepant, an oral calcitonin gene-related peptide receptor antagonist, alleviated the pain and most bothersome symptoms of migraine attacks.

Why this matters

  • Existing acute treatments have contraindications, limited effectiveness.

Key results

  • Pain freedom at 2 hours:
    • 14.3% with placebo.
    • 21.8% with ubrogepant 50 mg (absolute difference, 7.5%; P=.01).
    • 20.7% with ubrogepant 25 mg (absolute difference, 6.4%; P=.03).
  • Absence of most bothersome associated symptom at 2 hours:
    • 27.4% with placebo.
    • 38.9% with ubrogepant 50 mg (absolute difference, 11.5%; P=.01).
    • 34.1% with ubrogepant 25 mg (absolute difference, 6.7%; P=.07).
  • Most common adverse events within 48 hours:
    • Nausea (placebo, 2.0%; 50 mg, 2.0%; 25 mg, 2.5%).
    • Dizziness (placebo, 1.6%; 50 mg, 1.4%; 25 mg, 2.1%).

Study design

  • Multicenter phase 3 randomized controlled trial among 1686 adults with migraine, with or without aura, having 2-8 migraine attacks monthly (ACHIEVE II trial).
  • Randomization: ubrogepant 50 mg, ubrogepant 25 mg, placebo for single migraine attack of moderate or severe pain intensity.
  • Main outcomes: pain freedom, absence of patient-designated most bothersome migraine-associated symptom (photophobia, phonophobia, or nausea).
  • Funding: Allergan PLC.

Limitations

  • Treatment not initiated until headache pain moderate or severe.
  • Efficacy in subsequent attacks not assessed.
  • Adverse events, tolerability assessed after single use.