Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study

What Was Tested

The paper reports a study of CGRP (Calcitonin Gene-Related Peptide) in the context of migraine, published as a clinical trial, phase iii.

ZAV 10-mg nasal spray is the first intranasal, small-molecule CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults.

Who Took Part

PubMed indexes the participants as young adults, adults and middle-aged adults, both men and women.

This was a subgroup analysis of data from a multicenter, single-arm, open-label, phase 2/3 clinical trial that assessed the safety and tolerability of ZAV for the acute treatment of migraine.

How the Study Was Run

The design is described as open-label and multicenter.

Everyone knew when CGRP (Calcitonin Gene-Related Peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the participants came from several places.

Adverse events (AEs), clinical laboratory results, and vital signs data were evaluated and summarized descriptively.

What Was Measured

Topics PubMed links to this paper include Migraine Disorders, Calcitonin Gene-Related Peptide Receptor Antagonists, Calcitonin Gene-Related Peptide, Nasal Sprays, Antibodies, Monoclonal and Antibodies, Monoclonal, Humanized.

Author keywords: calcitonin gene‐related peptide receptor antagonist, clinical trial, preventive migraine treatment, safety and zavegepant.

What This Means in Plain Language

The paper is an open-label and multicenter study of CGRP (Calcitonin Gene-Related Peptide) in people with migraine.

The abstract goes on to report its results in about 13 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2025 (Headache), a journal based in United States.

More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.