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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Profiling Subjects With Migraine
- ClinicalTrials.gov ID
- NCT07832032
- Acronym / sponsor ID
- BioM / REK 1013498
- Conditions
- Migraine
- Keywords
- Neuropeptides, Exosomes, miRNA, Biological rhythms, Biomarker, Migraine, Hypothalamus, Neurotrophins
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 17 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimegepant 75 MGAlso: VyduraStudy 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®). | Drug | – |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karl B. Alstadhaug, MD, PhD principal investigator
Nordlandssykehuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Nordlandssykehuset HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl B. Alstadhaug, MD, PhD (+47 94781939, karl.bjornar.alstadhaug@nordlandssykehuset.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.