A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine.

ABSTRACT:

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

SUBMITTER: Camporeale A 

PROVIDER: S-EPMC6234796 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature