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Phase 2 trials have shown that blocking calcitonin gene-related peptide (CGRP) with the humanized monoclonal antibody (mAb) galcanezumab is effective in the preventive treatment of migraine. To further assess the efficacy of galcanezumab in a larger patient population, the drug was tested in a manufacturer-sponsored, phase 3, randomized, controlled trial.
Participants received one of two dosing regimens of galcanezumab (120 mg and 240 mg, injected subcutaneously) or placebo monthly for 6 months. The 862 participants fulfilled criteria for episodic migraine of 4 to 14 migraine headache days per month, and no other preventive medications were allowed. Patients who had not responded to previous migraine preventive treatment were excluded.
Compar…