CHERUB01
Trial question
What is the effect of erenumab in patients with chronic cluster headache?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 81
81 patients (21 female, 60 male).
Inclusion criteria: adult patients, aged 18-65 years, with chronic cluster headache.
Key exclusion criteria: prior therapy for chronic cluster headache with a calcitonin gene-related peptide-targeted monoclonal antibody; unable to differentiate cluster headache attacks from other headaches; use of a prophylactic cluster headache medication within 5 half-lives prior to the start of baseline phase; concurrent use of other therapeutic monoclonal antibodies; active chronic pain syndromes; major psychiatric disorder.
Interventions
N=41 erenumab (at a dose of 70 mg administered SC with 4 injections on day 1 and 2 injections at 4 weeks).
N=40 placebo (matching placebo administered SC with 4 injections on day 1 and 2 injections at 4 weeks).
Primary outcome
Mean reduction in weekly cluster headache attacks over weeks 5 and 6
7.3
5.9
7.3 attack...
5.5 attack...
3.6 attack...
1.8 attack...
0.0 attack...
Erenumab
Placebo
No significant
difference ↔
No significant difference in mean reduction in weekly cluster headache attacks over weeks 5 and 6 (7.3 attacks per week vs. 5.9 attacks per week; MD 1.5, 95% CI -0.07 to 3.07).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients, aged 18-65 years, with chronic cluster headache, erenumab was not superior to placebo with respect to mean reduction in weekly cluster headache attacks over weeks 5 and 6.
Reference
Jasper Mecklenburg, Charly Gaul, Mira Fitzek et al. Erenumab for Chronic Cluster Headache: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2516318.
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