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Completed

NCT Number: NCT05635604

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish headache center

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers of both sexes.
  • 18-60 years.
  • 50-100 kg.
  • Women of childbearing potential must use adequate contraception
  • History of migraine without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria.
  • No migraine preventive treatment.

Exclusion criteria

  • A history of serious somatic disease
  • > 50 years of age at migraine onset.
  • History of any other primary headaches disorder (except ≤ 5 monthly days with tension- type headache).
  • Daily intake of any medication except contraceptives

Treatment and study plan

Eptinezumab

Drug

Eptinezumab or ALD403 is a humanized anti-calcitonin gene-related peptide IgG1 monoclonal antibody that binds to calcitonin gene-related peptide (CGRP). It selectively binds human CGRP ligand to prevent activation of the CGRP receptor and blocks its binding to the receptor for the prevention of migraine.

PACAP-38

Drug

PACAP-38 is a naturally occurring peptide diffusely expressed throughout the body. The Danish Headache Center has used infusion of PACAP-38 for several years and the first time in 2007 where infusion of PACAP-38 triggered headaches and migraines in migraine patients.

Primary outcomes

  1. A subjective report of a migraine attack

    Time frame: Time of reporting migraine attack is from the baseline to 24 hours after eptinezumab/placebo administration.

    The participants report whether they feel a migraine attack (Yes or no).

Secondary outcomes

  1. Headache

    Time frame: Time of headache measurements is from from the baseline to 24 hours eptinezumab/placebo administration.

    Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache).

  2. Changes in the superficial temporal artery (STA).

    Time frame: Time of headache measurements is from from the baseline to 24 hours eptinezumab/placebo administration.

    Diameter of the frontal branch of the superficial temporal artery (STA).

    Repeated measurements covering the diameter of STA before and after eptinezumab/placebo administration and PACAP-38 infusion measured by millimeters (mm).

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Molecular Stratification of Signaling Pathways Underlying Migraine Pathophysiology.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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