This Phase II study evaluated the safety and efficacy of TEV-48125 for preventive treatment of chronic migraine (≥15 headache-days per month); a study evaluating it in patients with high-frequency episodic migraine (<15 headache-days per month) has also been published. In both studies it was given subcutaneously once a month and concomitant oral preventative drugs and some use of opioids were allowed, reflecting daily clinical practice.
The authors of a related comment say that the short-term efficacy and excellent tolerability of the investigational antibody anti-calcitonin gene-related peptide (CGRP) antibody in patients with the most difficult types of migraine confirm the promise of these agents for migraine prevention. Some questions however remain and need to be addressed in further studies; for example is there a subset of patients in whom other molecules cause migraine pain, in whom agents targeting CGRP would be insufficient? The authors of the commentary conclude that the characteristics of responders to these antibodies, their ideal dose, and their long-term neurological and systemic safety need to be refined.