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IN VITRO METHODS FOR THE DIAGNOSIS OF MIGRAINE AND FOR THE DIFFERENTIAL DIAGNOSIS OF CHRONIC AND EPISODIC MIGRAINECM Patents

Índice de la ficha

Updated at
24/07/2026
Numero publicacion
EP.4653547.A1
Fecha publicacion
26/11/2025
Numero solicitud
EP20240382538
Fecha presentacion
20/05/2024

En detalle

Resumen

[0001] The present invention refers to the medical field. Particularly, the present invention refers to an in vitro method for the diagnosis of migraine which comprises based on the assessment of the expression level of miR-375 in a biological sample obtained from a subject. It also refers to an in vitro method for the differential diagnosis of chronic and episodic migraine based on the assessment of the expression level of miR-375 in a biological sample obtained from a subject. It also refers to the in vitro use of the expression level of miR-375 for the diagnosis of migraine, or for the differential diagnosis of chronic and episodic migraine. In a preferred embodiment, the assessment of the expression level of miR-375 is combined with the assessment of other miRNAs or MRI parameters.

Reivindicaciones

1. In vitro method for the diagnosis of migraine which comprises: (a) assessing the expression level of miR-375 in a biological sample obtained from a subject, b) wherein the identification of a lower expression level, as compared with a pre-established threshold value determined in subjects that do not suffer from migraine or by comparing subjects that suffer from migraine with subjects that do not suffer from migraine, is an indication that the subject suffers from migraine. 2. In vitro method for the diagnosis of migraine, according to claim 1, which comprises: (a) assessing the expression level of miR-375 in combination with the expression level of a miRNA selected from: miR-200a-3p, miR-141-3p, miR-454-3p and/or miR-16-2-3p in a biological sample obtained from a subject, b) wherein the identification of a lower expression level, as compared with a pre-established threshold value determined in subjects that do not suffer from migraine or by comparing subjects that suffer from migraine with subjects that do not suffer from migraine, is an indication that the subject suffers from migraine. 3. In vitro method for the diagnosis of migraine, according to any of the claims 1 or 2, which comprises: (a) assessing the expression level of the following combinations of miRNAs: miR-375 and miR-200a-3p, miR-375 and miR-454-3p; and/or miR-375 and miR-16-2-3p in a biological sample obtained from a subject, b) wherein the identification of a lower expression level of the combination of miR-375 and miR-200a-3p, miR-375 and miR-454-3p; and/or miR-375 and miR-16-2-3p, as compared with a pre-established threshold value determined in subjects that do not suffer from migraine or by comparing subjects that suffer from migraine with subjects that do not suffer from migraine, is an indication that the subject suffers from migraine. 4. In vitro method for the diagnosis of migraine, according to any of the claims 1 or 3, which further comprises assessing the area of the right superior frontal gyrus, preferably by magnetic resonance imaging (MRI), wherein a lower surface area of the right superior frontal gyrus, as compared with a pre-established threshold value determined in subjects that do not suffer from migraine or by comparing subjects that suffer from migraine with subjects that do not suffer from migraine, is an indication that the subject suffers from migraine. 5. In vitro method for the diagnosis of migraine, according to any of the claims 1 or 4, wherein the migraine is chronic migraine or episodic migraine. 6. In vitro method for the differential diagnosis of chronic and episodic migraine which comprises: (a) assessing the expression level of miR-375 in a biological sample obtained from a subject, b) wherein the identification of a lower expression level, as compared with a pre-established threshold value determined in subjects that suffer from episodic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from chronic migraine, and c) wherein the identification of a higher expression level, as compared with a pre-established threshold value determined in subjects that suffer from chronic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from episodic migraine. 7. In vitro method for the differential diagnosis of chronic and episodic migraine, according to claim 6, which comprises: (a) assessing the expression level of miR-375 in combination with the expression level of a miRNA selected from: miR-200a-3p, miR-141-3p, miR-454-3p and/or miR-16-2-3p in a biological sample obtained from a subject, b) wherein the identification of a lower expression level, as compared with a pre-established threshold value determined in subjects that suffer from episodic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from chronic migraine, and c) wherein the identification of a higher expression level, as compared with a pre-established threshold value determined in subjects that suffer from chronic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from episodic migraine. 8. In vitro method for the differential diagnosis of chronic and episodic migraine, according to any of the claims 6 or 7, which comprises: a) assessing the expression level of the following combinations of miRNAs: miR-375 and miR-200a-3p, miR-375 and miR-454-3p; and/or miR-375 and miR-16-2-3p in a biological sample obtained from a subject, b) wherein the identification of a lower expression level, as compared with a pre-established threshold value determined in subjects that suffer from episodic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from chronic migraine, and c) wherein the identification of a higher expression level, as compared with a pre-established threshold value determined in subjects that suffer from chronic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from episodic migraine. 9. In vitro method for the differential diagnosis of chronic an episodic migraine, according to any of the claims 6 to 8, which further comprises: a) assessing the area of the right superior frontal gyrus by magnetic resonance imaging (MRI) of the subject, b) wherein a lower surface area of the right superior frontal gyrus, as compared with a pre-established threshold value determined in subjects that suffer from episodic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from chronic migraine, and c) wherein a higher surface area of the right superior frontal gyrus, as compared with a pre-established threshold value determined in subjects that suffer from chronic migraine or by comparing subjects that suffer from episodic and chronic migraine, is an indication that the subject suffers from episodic migraine. 10. In vitro method, according to any of the previous claims, wherein the biological sample is selected from serum-derived extracellular vesicles, plasma-derived extracellular vesicles, blood-derived extracellular vesicles, blood, serum or plasma, preferably wherein the biological sample is serum-derived extracellular vesicles. 11. In vitro use of the expression level of miR-375 for the diagnosis of migraine, or for the differential diagnosis of chronic and episodic migraine. 12. In vitro use, according to claim 11, of the expression level of miR-375 in combination with the expression level of a miRNA selected from: miR-200a-3p, miR-141-3p, miR-454-3p and/or miR-16-2-3p for the diagnosis of migraine, or for the differential diagnosis of chronic and episodic migraine. 13. In vitro use, according to any of the claims 11 or 12, of the expression level of the following combinations of miRNA: miR-375 and miR-200a-3p, miR-375 and miR-454-3p, and/or miR-375 and miR-16-2-3p for the diagnosis of migraine, or for the differential diagnosis of chronic and episodic migraine. 14. In vitro use, according to any of the claims 11 to 13, in combination with the assessment the area of the right superior frontal gyrus by magnetic resonance imaging (MRI). 15. In vitro use, according to claims 11 to 14, wherein the diagnosis of migraine is the diagnosis of chronic or episodic migraine.

Etiquetas

Inventores
Sánchez Madrid FranciscoVivancos Mora JoséGonzález Martínez AliciaDe la Fuente HortensiaGago-Veiga Ana BeatrizPlanchuelo Gómez ÁlvaroGuerrero Peral Ángel Luis
Solicitantes
Universidad Autónoma de MadridFundación Para la Investigación Biomédica del Hospital Universitario la PrincesaFundacion Para la Investigacion Biomedica del Hospital Univ la PrincesaUniv ValladolidGerencia Regional de Salud de Castilla y León
Clasificacion ipc
C12Q 1/ 6883 A I
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