Galcanezumab cuts frequency of cluster headache attacks

  • Goadsby PJ & al.
  • N Engl J Med
  • 11 Jul 2019

  • International Clinical Digest
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Takeaway

  • Galcanezumab is efficacious and well-tolerated for reducing attacks of episodic cluster headache.

Why this matters

  • NICE has initiated a review of galcanezumab for cluster headache.

Key results

  • Recruitment stopped early because too few patients met eligibility criteria.
  • Relative to placebo group, galcanezumab group had greater:
    • Mean reduction in weekly frequency of cluster headache attacks across weeks 1-3 (–8.7 vs –5.2 weekly attacks; P=.04).
    • Percentage of patients achieving reduction of ≥50% in headache frequency at week 3 (71% vs 53%; P=.046).
  • Galcanezumab group had higher incidence of injection-site pain (8% vs 0%; P=.04).
  • Incidence of other adverse events not significantly different.
  • No serious adverse events, deaths in either group.

Study design

  • International phase 3 randomised controlled trial among 106 patients:
    • ≥1 attack every other day.
    • ≥4 total attacks.
    • ≤8 attacks per day during baseline assessment.
    • History of cluster headache periods lasting ≥6 weeks.
  • Randomisation: galcanezumab (300 mg) vs placebo, subcutaneously at baseline and at 1 month.
  • Main outcome: mean change in weekly frequency of cluster headache attacks across weeks 1-3 after first dose.
  • Funding: Eli Lilly.

Limitations

  • Fairly small trial population.
  • Shorter trial duration.