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NCT Number: NCT07832032

Biological Profiles of Neuropeptides, Neurotrophins and miRNA in Migraine

There are still no reliable biomarkers for migraine; the diagnosis is based on symptomatology, and the pathogenesis remains largely a mystery. However, the past decade has seen a shift from a trial-and-error treatment strategy to a more biologically driven approach using CGRP-targeted drugs (gepants) and monoclonal antibodies (mAbs). This study aims to profile levels of perivascular and hypothalamic neuropeptides, as well as microRNA (miRNA) and neurotrophins, in individuals with migraine. The study builds on a previous pilot investigation (Neuropeptides during migraine attacks, REK 808581).

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Headache Disorders Headache Disorders, Primary Kidney Diseases Male Urogenital Diseases Migraine Disorders Nervous System Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement of Neurology, NLSH HF

Bodø, 8005, Norway

Location contact

Karl B Alstadhaug, MD, PhD

CONTACT

[email protected]

+4794781939

Karl M Alstadhaug, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

The aim of the study will be achieved by collecting and analyzing blood, saliva, and tears from 30 individuals with migraine and 30 healthy age-, gender- and socio-occupationally matched controls (T0). All the participants will be recruited among the hospital personnel at Nordland Hospital.

Participants with migraine who experience an attack at work during daytime within a 6-month period will immediately contact study staff and undergo collection of blood, saliva and tear fluid (T1). They will then receive oral dissolving rimegepant (Vydura®), which is an effective and legislated treatment of migraine attacks. Two hours later, treatment response and adverse effects will be assessed and new samples collected (T2). The same procedure will be performed 24 hours later (T3). Samples will be collected, handled and analyzed according to our in-house procedures and stored in the Neurological Biobank until analysis.

Who can participate

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

Inclusion criteria

  • Informed and written consent.
  • Men and women, between 18 and 55 years of age.
  • Master a Scandinavian language at level sufficient to fully understand the written and verbal study information.
  • Migraine, with or without aura, fulfilling the International Classification of Headache Disorders (ICHD) III criteria for episodic migraine at time of inclusion. They must report at least 1 attack per month requiring the use of acute medication.
  • Consent to fill out a headache diary for up to 6 months.

Exclusion criteria

  • Pregnancy
  • Smoking
  • The subject is unable to differentiate migraine from other concomitant headaches
  • The subject having chronic migraine or other chronic pain conditions
  • The subject has severe psychiatric disorders (including depression), substance abuse, severe somatic disorders, and any medical condition that could alter tear and saliva production.
  • Eye disorders that cause pain, require medication or affect tear production.
  • Subjects using tricyclic antidepressant or CGRP antagonists.
  • Contraindication for gepants.

Treatment and study plan

Rimegepant 75 MG

Drug

Study subjects who during a 6-month period experience a migraine attack at work during daytime will contact study staff immediately and come for collection of blood, saliva and tear fluid samples. After that they will be treated with the oral dissolving CGRP receptor antagonist rimegepant tablet (Vydura®).

Other names: Vydura

Primary outcomes

  1. Delta C during attacks

    Time frame: Changes from baseline (T0) to early migraine attack phase (T1), to 2 hours post-rimegepant treatment to 24 hours post-migraine ictus. The time frame from baseline to the migraine attack cannot exceed 6 months.

    The concentration of miRNA, neuropeptides, and neurotrophins in plasma, tear fluid, and saliva during the interictal phase compared to the ictal phase of migraine.

Secondary outcomes

  1. Delta C during the interictal phase

    Time frame: Difference in baseline (T0) concentrations between subjects with migraine and healthy controls. These concentrations are measured at a single timepoint during a year of recruitment.

    The concentration of the miRNA, neuropeptides and neurotrophins in plasma, tear fluid and saliva interictally in subjects with migraine compared with matched controls.

  2. Correlations 1

    Time frame: Correlations between concentrations of measured substances in different tissues will be analyzed at individual time points: at the start (T0), early during a migraine attack (T1), 2 hours after treating the attack (T2), and 24 hours after the migraine.

    Correlations between concentrations in plasma, tear fluid and saliva

  3. Associations

    Time frame: Correlation, regression, and time-series dependences between concentrations of measured substances at individual timepoints (T0, T1, T2, T3) and self-reported triggers, premonitory symptoms and treatment response.

    Correlations between sample concentrations and triggers, premonitory symptoms and treatment response.

Study contacts

Contact information is provided by the study sponsor or research team.

Karl B. Alstadhaug, MD, PhD

CONTACT

[email protected]

+47 94781939

Petter Øien

CONTACT

[email protected]

+47 95915892

Sponsors and collaborators

Lead sponsor

Nordlandssykehuset HF

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Biological Profiling Subjects With Migraine

Acronym: BioM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

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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