- 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.
- 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.
- 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.
- Fairly small trial population.
- Shorter trial duration.