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Expression of miR-155 in Migraine: Association With Different Phenotypes and Disease Severity
Sponsor study identifier
observational
90
1 country
1
Study Start
September 22, 2020
Actual (reported)Primary Completion
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Migraine is a common, yet often disabling, neurological disease that affects over 1 billion people around the world. It's the second most disabling disease globally and the leading cause of disability for people under the age of 50, especially women. The effects of migraine aren't limited to the individual, with a tremendous economic impact on families, friends, and employers. To help reduce this burden, research is now focusing on developing biomarkers that can help with diagnosis, predicting response to treatments, and identifying those at risk of developing chronic migraine. MicroRNAs (miRNAs) are one of the most promising classes, as they can modulate gene expression and affect a wide range of cellular processes. Other studies have already observed different miRNA expression in those with episodic migraine or chronic migraine, but no specific miRNAs have been identified as a strong and specific migraine signature. miRNA-155 is of particular interest, as it has been linked to inflammation and pain, and may be a potential target for migraine treatments. It is known that the immune system plays a role in migraine headaches. Monocytes, a type of immune cell, may be involved in the development of migraines. Certain medicines, such as aspirin, can affect monocyte function and have been used to treat migraines. Recent research has also shown that microRNAs can regulate the activity of these cells and influence inflammation, which may be linked to migraine attacks. This study aims to investigate the role of miRNA-155 and monocyte differentiation in migraine patients, and in particular its association with migraine phenotype and severity. We aim to study three groups of subjects: Episodic migraine (EM), Chronic migraine with or without Medication Overuse Headache (CM-MOH) and Healthy Controls (HCs).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2020
Actual (reported)May 26, 2023
Actual (reported)June 7, 2023
Actual (reported)January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Comparison of miR-155 expression in peripheral monocytes between the three study groups: chronic migraine, episodic migraine and healthy control.
miRNA-155 gene expression will be evaluated by real-time reverse transcription (RT-PCR). This assessment will be then normalized with U6 (a type of small nuclear RNA used as housekeeping gene) and expressed as Relative Quantification (RQ).
Baseline (T0).
Cytofluorimetric evaluation of monocytes to determine their phenotype and subtype and the different colocalization of these between the three study groups: chronic migraine, episodic migraine and healthy control.
Baseline (T0).
Comparison of gene expression in peripheral monocytes of pro-inflammatory (IL-1B, TNF-alpha) and anti-inflammatory (IL-10) cytokines between the three study groups: chronic migraine, episodic migraine and healthy control.
Healthy subjects without present or past history of headache according to ICHD-III criteria.
Patients with a diagnosis of migraine without or with aura, with episodic pattern, according to ICHD-III criteria.
Patients with a diagnosis of chronic migraine with or without medication overuse headache according to ICHD-III criteria.
We aim to enroll a representative population of patients affected by EM and CM-MOH. All patients will be consecutively enrolled among those attending the clinics of the Headache Science Center of the IRCCS Mondino Foundation of Pavia (Italy). A set of healthy controls, without a diagnosis of present or past headache, will be enrolled as control group.
IRCCS Mondino Foundation
Pavia, 27100, Italy
Essandoh K, Li Y, Huo J, Fan GC. MiRNA-Mediated Macrophage Polarization and its Potential Role in the Regulation of Inflammatory Response. Shock. 2016 Aug;46(2):122-31. doi: 10.1097/SHK.0000000000000604.
Yamanaka G, Suzuki S, Morishita N, Takeshita M, Kanou K, Takamatsu T, Suzuki S, Morichi S, Watanabe Y, Ishida Y, Go S, Oana S, Kashiwagi Y, Kawashima H. Role of Neuroinflammation and Blood-Brain Barrier Permutability on Migraine. Int J Mol Sci. 2021 Aug 19;22(16):8929. doi: 10.3390/ijms22168929.
First Submitted
May 26, 2023
First Posted
June 7, 2023
Study Start
September 22, 2020
Actual (reported)Primary Completion
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Baseline (T0).
Comparison of miR-382-5p and miR-34a-5p expressions in peripheral monocytes between the three study groups: chronic migraine, episodic migraine and healthy control.
Baseline (T0).
Contact the study team to confirm eligibility.
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.
Ashina M, Terwindt GM, Al-Karagholi MA, de Boer I, Lee MJ, Hay DL, Schulte LH, Hadjikhani N, Sinclair AJ, Ashina H, Schwedt TJ, Goadsby PJ. Migraine: disease characterisation, biomarkers, and precision medicine. Lancet. 2021 Apr 17;397(10283):1496-1504. doi: 10.1016/S0140-6736(20)32162-0. Epub 2021 Mar 25.
Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.
Gazerani P. Current Evidence on Potential Uses of MicroRNA Biomarkers for Migraine: From Diagnosis to Treatment. Mol Diagn Ther. 2019 Dec;23(6):681-694. doi: 10.1007/s40291-019-00428-8.
Gallardo VJ, Gomez-Galvan JB, Asskour L, Torres-Ferrus M, Alpuente A, Caronna E, Pozo-Rosich P. A study of differential microRNA expression profile in migraine: the microMIG exploratory study. J Headache Pain. 2023 Feb 17;24(1):11. doi: 10.1186/s10194-023-01542-z.
Greco R, Bighiani F, Demartini C, Zanaboni A, Francavilla M, Facchetti S, Sproviero D, Vaghi G, Allena M, Martinelli D, Corrado M, Guaschino E, Ghiotto N, Bottiroli S, Cammarota F, Antoniazzi A, Grillo V, Sances G, Tassorelli C, De Icco R. miR-382-5p and miR-34a in migraine: Expression in monocytes and a post-hoc exploratory comparison with expression in peripheral blood mononuclear cells. Cephalalgia. 2025 Dec;45(12):3331024251386769. doi: 10.1177/03331024251386769. Epub 2025 Dec 4.
Greco R, Bighiani F, Demartini C, Zanaboni A, Francavilla M, Facchetti S, Vaghi G, Allena M, Martinelli D, Guaschino E, Ghiotto N, Bottiroli S, Corrado M, Cammarota F, Antoniazzi A, Mazzotta E, Pocora MM, Grillo V, Sances G, Tassorelli C, De Icco R. Expression of miR-155 in monocytes of people with migraine: association with phenotype, disease severity and inflammatory profile. J Headache Pain. 2024 Aug 27;25(1):138. doi: 10.1186/s10194-024-01842-y.
Study Completion
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 8, 2023
Record last verified: 2023-06
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