Biological Profiles of Neuropeptides, Neurotrophins and miRNA in Migraine
Migraine
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 55 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No informado
- Participantes
- 60 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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).
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Población del estudio
The individuals eligible for inclusion in this study are employees at Nordland hospital who sometimes use to experience migraine attacks at work during daytime.
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- No informado
- Enmascaramiento
- No informado
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®).
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Delta C during attacks
Plazo: 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.
Medidas secundarias
Delta C during the interictal phase
Plazo: 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
Plazo: 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
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Departement of Neurology, NLSH HFBodø, NorwayEstado desconocido
Equipo y fechas
- Patrocinador principal
- Nordlandssykehuset HF
- Inicio del estudio
- 5 nov 2026 Real
- Finalización primaria
- 31 dic 2027 Estimado
- Finalización del estudio
- 31 dic 2027 Estimado
- Primera publicación
- 21 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Biological Profiling Subjects With Migraine
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026