GALiC
(2019)Objective
Galcanezumab - To evaluate the efficacy and safety of galcanezumab in preventing attacks of episodic cluster headache.
Study Summary
• Galcanezumab significantly reduced the frequency of cluster headache attacks over 3 weeks.
• Higher responder rates compared to placebo.
• Generally well tolerated, with mild injection-site pain.
• Higher responder rates compared to placebo.
• Generally well tolerated, with mild injection-site pain.
Intervention
Randomized, double-blind, placebo-controlled trial across 35 centers in Europe and North America. Patients with episodic cluster headache were randomized to receive 300 mg galcanezumab or placebo subcutaneously at baseline and at 1 month. The trial included an 8-week double-blind period.
Inclusion Criteria
Adults aged 18–65 with episodic cluster headache (≥1 attack every other day, ≥4 total attacks, ≤8 attacks/day, and a cluster period lasting ≥6 weeks).
Study Design
Arms: Galcanezumab 300 mg vs. Placebo
Patients per Arm: 49 (galcanezumab), 57 (placebo)
Outcome
• Mean reduction in weekly attacks (weeks 1–3): –8.7 with galcanezumab vs. –5.2 with placebo (difference: –3.5 attacks; 95% CI: 0.2 to 6.7; p=0.04).
• ≥50% reduction in weekly attacks at week 3: 71% (galcanezumab) vs. 53% (placebo); p=0.046.
• Adverse events: 43% (galcanezumab) vs. 33% (placebo); injection-site pain in 8% of galcanezumab group.
• ≥50% reduction in weekly attacks at week 3: 71% (galcanezumab) vs. 53% (placebo); p=0.046.
• Adverse events: 43% (galcanezumab) vs. 33% (placebo); injection-site pain in 8% of galcanezumab group.