ClinicalTrials.gg
Enrolling by invitationNCT07832032BioMUpdated Nov 10, 2026

Biological Profiles of Neuropeptides, Neurotrophins and miRNA in Migraine

An observational study in Migraine, sponsored by Nordlandssykehuset HF. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Nordlandssykehuset HF · Observational

Updated Nov 10, 2026Now Enrolling by invitationStart date movedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Migraine

Keywords

  • Neuropeptides
  • Exosomes
  • miRNA
  • Biological rhythms
  • Biomarker
  • Migraine
  • Hypothalamus
  • Neurotrophins
  • CGRP
  • PACAP
  • Oxytocin-neurophysin I prepropetide
  • Copeptin
  • Amylin
  • Sex hormones
  • Lactoferrin
  • Vasoactive intestinal peptide
  • Substance P
  • Vasopressin
  • Oxytocin
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 60 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Nordlandssykehuset HF is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The individuals eligible for inclusion in this study are employees at Nordland hospital who sometimes use to experience migraine attacks at work during daytime.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Informed and written consent.
  2. Men and women, between 18 and 55 years of age.
  3. Master a Scandinavian language at level sufficient to fully understand the written and verbal study information.
  4. 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.
  5. Consent to fill out a headache diary for up to 6 months.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Smoking
  3. The subject is unable to differentiate migraine from other concomitant headaches
  4. The subject having chronic migraine or other chronic pain conditions
  5. The subject has severe psychiatric disorders (including depression), substance abuse, severe somatic disorders, and any medical condition that could alter tear and saliva production.
  6. Eye disorders that cause pain, require medication or affect tear production.
  7. Subjects using tricyclic antidepressant or CGRP antagonists.
  8. for gepants.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • 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®).

    Also known as: Vydura

06

What researchers measure

Primary outcomes

  1. Delta C during attacks

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

    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.

Secondary outcomes

  1. Delta C during the interictal phase

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

    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.

  2. Correlations 1

    Correlations between concentrations in plasma, tear fluid and saliva

    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.

  3. Associations

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

    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.

07

Study locations

1 site
  • Departement of Neurology, NLSH HF
    Bodø, 8005, Norway
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Enrolling by invitation
changed Nov 10, 2026
Start date
Sep 17, 2026→Nov 5, 2026 (actual)
Nov 10, 2026
Contact
No study contact listed any more: removed k•••@nordlandssykehuset.no · •••1939; removed p•••@nordlandssykehuset.no · •••5892
Nov 10, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Departement of Neurology, NLSH HF · Bodø, NorwayContact removed k•••@nordlandssykehuset.no · •••1939Contact removed (no phone or email listed)
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Not yet recruiting→Enrolling by invitation
    Start date Sep 17, 2026→Nov 5, 2026 (now actual)
    Contact No study contact listed any more: removed k•••@nordlandssykehuset.no · •••1939; removed p•••@nordlandssykehuset.no · •••5892
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Departement of Neurology, NLSH HF · Bodø, NorwayContact removed k•••@nordlandssykehuset.no · •••1939Contact removed (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07832032
Lead sponsor
Nordlandssykehuset HF
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Nov 5, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Karl B. Alstadhaug, MD, PhD
principal investigator · Nordlandssykehuset

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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