Home > Publications Database > Efficacy and safety of mAbs anti-CGRP/CGRP R (eptinezumab and erenumab) or atogepant in combination with onabotulinumtoxinA in refractory chronic migraine: a clinical trial protocol. |
Journal Article | DZNE-2025-00532 |
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2025
Taylor & Francis
London
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Please use a persistent id in citations: doi:10.1080/17581869.2025.2487413
Abstract: Chronic migraine is a disabling neurovascular disorder that represents the leading cause of years lived with disability in people under 50 with a remarkable social burden due to widespread resistance to the front-line treatments used routinely in current clinical practice. The present study investigates the efficacy and safety of combination therapy using eptinezumab and erenumab, recently approved monoclonal antibodies (mAbs) directed against calcitonin gene-related peptide or its receptor, respectively, or the receptor competitive antagonist atogepant together with botulinum toxin type A in chronic migraine that has proven resistant to front-line treatments for at least 6 weeks. To this aim a retrospective and a prospective phase are designed. Furthermore, a feasible salivary biomarker of migraine is under investigation in the prospective stage of the study. Based on recent expert opinions supporting the switch to easy-to-use small molecule calcitonin gene-related peptide (CGRP)-targeting, i.e. rimegepant or atogepant in unresponsive patients, the present study may offer to clinicians a novel treatment to enhance the therapeutic preventive machinery in chronic migraine.
Keyword(s): Migraine Disorders: drug therapy (MeSH) ; Humans (MeSH) ; Botulinum Toxins, Type A: therapeutic use (MeSH) ; Botulinum Toxins, Type A: administration & dosage (MeSH) ; Antibodies, Monoclonal, Humanized: therapeutic use (MeSH) ; Antibodies, Monoclonal, Humanized: administration & dosage (MeSH) ; Antibodies, Monoclonal, Humanized: adverse effects (MeSH) ; Antibodies, Monoclonal, Humanized: pharmacology (MeSH) ; Calcitonin Gene-Related Peptide Receptor Antagonists: therapeutic use (MeSH) ; Calcitonin Gene-Related Peptide Receptor Antagonists: administration & dosage (MeSH) ; Drug Therapy, Combination (MeSH) ; Calcitonin Gene-Related Peptide: antagonists & inhibitors (MeSH) ; Prospective Studies (MeSH) ; Chronic Disease (MeSH) ; Retrospective Studies (MeSH) ; Adult (MeSH) ; Treatment Outcome (MeSH) ; Male (MeSH) ; CGRP receptor antagonists ; anti-CGRP monoclonal antibodies ; anti-CGRP-R monoclonal antibodies ; atogepant ; chronic migraine ; gepants ; onabotulinumtoxinA ; Botulinum Toxins, Type A ; erenumab ; Antibodies, Monoclonal, Humanized ; Calcitonin Gene-Related Peptide Receptor Antagonists ; eptinezumab ; onabotulinum toxin A ; Calcitonin Gene-Related Peptide
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