Biological Profiles of Neuropeptides, Neurotrophins and miRNA in Migraine
ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorNordlandssykehuset HF
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy
Smoking
The subject is unable to differentiate migraine from other concomitant headaches
The subject having chronic migraine or other chronic pain conditions
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Rimegepant 75 MG
DrugStudy 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®).
Treatment groups
No treatment groups listed
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nordlandssykehuset HF
Lead sponsor
Norwegian University of Science and Technology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: