Use of anti-CGRP monoclonal antibodies in pediatric migraine: first evaluations of a phase 3, randomized, double-blind, placebo-controlled study

Abstract text (incl. figure legends and references)
Objective: to date, prophylactic therapies for migraine include the use of antiepileptic drugs, calcium antagonists or antidepressants. In recent years, studies have been conducted on adults with the monoclonal antibody that binds the receptor of the peptide related to the calcitonin gene (GCRP), which competes specifically with the binding of CGRP to its receptor by inhibiting its function. CGRP modulates the nociceptive signal and is associated with the pathophysiology of migraine. Therapies currently available in children have limited efficacy. There is therefore a need for additional drugs. Methods: 8 patients with chronic migraine and 1 patient with episodic migraine were enrolled in the study according to the criteria of the International Classification of Headaches (ICHD-III). Patients with chronic migraine are in the following phases: 1 finished the study, 1 dropped out, 2 in the double-blind phase, 3 in the open-label and dose-blind phase, and 1 moved from the episodic migraine study to chronic. Results: among the 8 patients with chronic migraine, it can be stated that 4 patients reported a reduction in the frequency and intensity of monthly migraine attacks, 2 patients reported the ineffective therapy and 2 patients, in whom the double-blind phase was not started, are being evaluated. In three of the four patients with chronic migraine, who had a good response to therapy, a reduction in the frequency and intensity of monthly attacks was observed starting from the double-blind phase. Conclusion: to date our preliminary data on the efficacy of anti-CGRP antibodies in pediatric age, even if under evaluation, confirm what has been found in double-blind studies on the adult population, or the possibility of having a prophylactic drug specific and efficacy for migraine. However, more pediatric studies will be needed to confirm these preliminary results.