Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects (CGRP-RNA)
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|ClinicalTrials.gov Identifier: NCT04473976|
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : July 20, 2020
Migraine can manifest with an episodic or chronic pattern in a continuum of disease severity. Multiple factors are associated to the transformation of the pattern form episodic to chronic. Of these, the most consistently reported is the overuse of medications (MO) for the acute treatment of attacks. Knowledge of the mechanisms through which MO facilitates the transformation of episodic migraine (EM) into chronic migraine (CM) is very limited. In order insights into these mechanisms, the present study was aimed at identifying possible peripheral biomarkers associated to the 2 forms of migraine and to the presence of MO.
The investigators evaluated CGRP plasma levels and the expression of miR-34a-5p and miR-382-5p in peripheral blood mononuclear cells of subjects with episodic migraine (EM, n=27) and CM-MO (n=28). CM-MO group was also tested 2 months after an in-hospital detoxification protocol.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects: Toward the Identification of a Panel of Peripheral Biomarkers of Migraine?|
|Actual Study Start Date :||December 15, 2017|
|Actual Primary Completion Date :||April 15, 2019|
|Actual Study Completion Date :||June 15, 2019|
- Plasma levels of CGRP [ Time Frame: Day 0 at the enrolment ]In order to identify individual or a panel of potential biomarkers of migraine subtypes
- Expression of miRNAs in PBMCs [ Time Frame: Day 0 at the enrolment ]In order to identify individual or a panel of potential biomarkers of migraine subtypes
- Changes in CGRP levels [ Time Frame: Day1 - Two months after Day 0 ]In the subjects with CM-MO after detoxification in order to gather more insights into the mechanisms that are involved in the improvement of migraine pattern following the withdrawal of the overused medications.
- Changes in miRNAs levels [ Time Frame: Day 1 - Two months after Day 0 ]In the subjects with CM-MO after detoxification in order to gather more insights into the mechanisms that are involved in the improvement of migraine pattern following the withdrawal of the overused medications.
Biospecimen Retention: Samples Without DNA
Blood samples from the cubital vein of each patient was put into a 5 ml lavender tube. Plasma samples were prepared by centrifugation and then stored at -80°C. Plasma CGRP levels were measured using a commercial enzyme-linked immuno-sorbent assay kit.
The miRNAs expression was evaluated by real-time reverse transcription (RT) Polymerase Chain Reaction (PCR) in peripheral blood mononuclear cell (PBMCs). PBMCs were isolated immediately after blood collection. Blood samples were collected within ethylenediamine tetra-acetic acid (EDTA) containing tube and diluted in 1:1 ratio with Phosphate Buffer Saline (PBS). Then, diluted blood samples were slowly loaded into Ficoll separating solution (15 ml) (Sigma) and centrifuged at 800 g for 30 min at room temperature. PBMCs accumulated as the middle white monolayer, were washed twice in sterile PBS at 300 g for 15 min. After washing, PBMCs pellet was resuspended in trizol and stored at -80 °C until use.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473976
|Headache Science Center|
|Pavia, Italy, 27100|
|Principal Investigator:||Cristina Tassorelli, Prof||IRCCS Mondino Foundation, Pavia|