Trials / Completed
CompletedNCT04659226
MicroRNA Profile and Erenumab Treatment
MicroRNA Profile in Women With Migraine Before and After Treatment With Erenumab
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University of L'Aquila · Academic / Other
- Sex
- Female
- Age
- 25 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug. The use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. Migraine is a complex disorder with several genetic and epigenetic influence, including that of microRNA. Several microRNAs, including those of inflammation and of endothelial function, have high expression levels in subjects with migraine; however, the findings of the available studies are insufficient to provide epigenetic biomarkers for migraine. Besides, little evidence is available on the role of migraine preventive treatments in the expression of microRNA. The study aims at evaluating the expression profiles of microRNAs before and after erenumab treatment prescribed according to clinical indication. The study will include women with episodic or chronic migraine treated with erenumab 140 mg monthly according to the Summary of Product Characteristics and local reimbursement criteria. The study will compare the expression profile of microRNAs in women with episodic and chronic migraine; besides, it will investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, pain intensity, response to erenumab, migraine-related impact and disability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Blood sampling for microRNA testing | Blood samples will be collected and analyzed for the microRNA profile by means of microfluidic cards |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2022-12-31
- Completion
- 2023-04-30
- First posted
- 2020-12-09
- Last updated
- 2024-05-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04659226. Inclusion in this directory is not an endorsement.