BACKGROUND: Galcanezumab, a humanized monoclonal antibody that selectively binds 
to the calcitonin gene-related peptide, has demonstrated in previous Phase 2 and 
Phase 3 clinical studies (≤6-month of treatment) a reduction in the number of 
migraine headache days and improved patients' functioning. This study evaluated 
the safety and tolerability, as well as the effectiveness of galcanezumab for up 
to 12 months of treatment in patients with migraine.
METHODS: Patients diagnosed with episodic or chronic migraine, 18 to 65 years 
old, that were not exposed previously to galcanezumab, were randomized to 
receive galcanezumab 120 mg or 240 mg, administered subcutaneously once monthly 
for a year. Safety and tolerability were evaluated by frequency of 
treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and 
adverse events (AEs) leading to study discontinuation. Laboratory values, vital 
signs, electrocardiograms, and suicidality were also analyzed. Additionally, 
overall change from baseline in the number of monthly migraine headache days, 
functioning, and disability were assessed.
RESULTS: One hundred thirty five patients were randomized to each galcanezumab 
dose group. The majority of patients were female (> 80%) and on average were 
42 years old with 10.6 migraine headache days per month at baseline. 77.8% of 
the patients completed the open-label treatment phase, 3.7% of patients 
experienced an SAE, and 4.8% discontinued due to AEs. TEAEs with a 
frequency ≥ 10% of patients in either dose group were injection site pain, 
nasopharyngitis, upper respiratory tract infection, injection site reaction, 
back pain, and sinusitis. Laboratory values, vital signs, or electrocardiograms 
did not show anyclinically meaningful differences between galcanezumab 
dosesOverall mean reduction in monthly migraine headache days over 12 months for 
the galcanezumab dose groups were 5.6 (120 mg) and 6.5 (240 mg). Level of 
functioning was improved and headache-related disability was reduced in both 
dose groups.
CONCLUSION: Twelve months of treatment with self-administered injections of 
galcanezumab was safe and associated with a reduction in the number of monthly 
migraine headache days. Safety and tolerability of the 2 galcanezumab dosing 
regimens were comparable.
TRIAL REGISTRATION: ClinicalTrials.gov as NCT02614287 , posted November 15, 
2015. These data were previously presented as a poster at the International 
Headache Congress 2017: PO-01-184, Late-Breaking Abstracts of the 2017 
International Headache Congress. (2017). Cephalalgia, 37(1_suppl), 319-374.