The study of migraine induction properties of PACAP-38 in patients without aura

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Danish Headache Center is recruiting patients for the clinical trial of Migraine Induction Properties of PACAP-38 After Eptinezumab in Migraine Without Aura Patients.

To investigate whether administration of calcitonin gene-related peptide (CGRP) binding monoclonal antibodies eptinezumab prevents pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) induced migraine attacks in migraine without aura patients.

The aim of the present study is to investigate whether - CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients. Clinical and basic research have established calcitonin gene-related peptide (CGRP) as central molecule in migraine pathophysiology, yet existing CGRP antagonizing therapies such as the CGRP and CGRP receptor binding monoclonal antibodies are only effective in 50-60% of migraine patients. PACAP-38 and CGRP colocalize in the trigeminovascular system, and both activate adenylate cyclase upon receptor binding which causes increased formation of cyclic AMP (cAMP). It is unknown if CGRP and PACAP-38 signaling pathways differ sufficiently for PACAP-38 to be an alternative treatment target to CGRP. Whether administration of CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients is yet to be investigated.

The study starts in December 2022 at the Danish headache center, Glostrup, Denmark. The indicative completion of the clinical trial will be expected in July 30, 2023.

The following population may be enrolled into this study: healthy volunteers of both sexes from 18 to 60 years, of 50 to 100 kg, with the history of migraine without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria and with no migraine preventive treatment. Women of childbearing potential must use adequate contraception.

Excluded will be those havong a history of serious somatic disease; having more than 50 years of age at migraine onset; history of any other primary headaches disorder (except ≤ 5 monthly days with tension- type headache); with daily intake of any medication except contraceptives can be enrolled into this research.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05634161.

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