MigraineBioMNCT07832032
Biological Profiles of Neuropeptides, Neurotrophins and miRNA in Migraine
An observational study of Migraine, run by Nordlandssykehuset HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant 75 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 17 Sep 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Departement of Neurology, NLSH HF
Bodø, 8005
Karl B Alstadhaug, MD, PhD, +4794781939, karl.bjornar.alstadhaug@nordlandssykehuset.no
Karl M Alstadhaug, MD, PhD
About this study
Official title: Biological Profiling Subjects With 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).
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.
- Conditions
- Migraine
- Being tested
- Rimegepant 75 MG
- 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
- Medical subject headings
- Migraine Disorders, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 MGDrug
Also called Vydura
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®).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 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.
Correlations 1
Correlations between concentrations in plasma, tear fluid and saliva
Measured: 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.
Associations
Correlations between sample concentrations and triggers, premonitory symptoms and treatment response.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start17 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Karl B. Alstadhaug, MD, PhD, Principal investigator, Nordlandssykehuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832032
- Sponsor's protocol ID
- REK 1013498
- Other IDs
- 1013498
- Acronym
- BioM
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No