Biological Profiles of Neuropeptides, Neurotrophins and miRNA in Migraine
Migraine
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 55 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not reported
- Participants
- 60 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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:
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. Contraindication for gepants.
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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
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®).
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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 measures
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.
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
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Departement of Neurology, NLSH HFBodø, NorwayStatus unknown
Study team and timeline
- Lead sponsor
- Nordlandssykehuset HF
- Study start
- Nov 5, 2026 Actual
- Primary completion
- Dec 31, 2027 Estimated
- Study completion
- Dec 31, 2027 Estimated
- First posted
- Sep 21, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Biological Profiling Subjects With Migraine
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026