Galcanezumab cuts frequency of cluster headache attacks

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.