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NCT Number: NCT04659226

MicroRNA Profile and Erenumab Treatment

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of L'Aquila

L’Aquila, 67100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 25 to 50 years
  • Chronic or episodic migraine with or without aura diagnosed according to the International Classification of Headache Disorders - 3rd edition
  • Receiving a first prescription of erenumab for migraine prevention according to the Summary of Product Characteristics and local reimbursement criteria
  • At least 1 year from migraine onset
  • Provided informed consent

Exclusion criteria

  • Headache other than migraine
  • Prior exposure to erenumab or other monoclonal antibodies targeting CGRP or its receptor
  • Use of any migraine preventive treatment in the last 60 days or 5 half-lives or 4 months if ever treated with botulinum toxin A
  • Pregnant or nursing
  • Body Mass Index <18 or >30 Kg/m2
  • Heavy smoking (more than 20 cigarettes per day)
  • Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedures within 12 months prior to first visit
  • Illicit drug abuse
  • Major psychiatric disorders
  • Infective or inflammatory diseases
  • Any chronic medication prescribed for indications different from migraine within 60 days before study initiation

Treatment and study plan

Blood sampling for microRNA testing

Genetic

Blood samples will be collected and analyzed for the microRNA profile by means of microfluidic cards

Primary outcomes

  1. Fold changes in microRNA serum concentration - Episodic migraine

    Time frame: 3 months per each patient

    Relative quantification of circulating microRNAs expression changes in women with episodic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx

  2. Fold changes in microRNA serum concentration - Chronic migraine

    Time frame: 3 months per each patient

    Relative quantification of circulating microRNAs expression changes in women with chronic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx

Secondary outcomes

  1. Baseline comparison between episodic and chronic migraine

    Time frame: Baseline

    Relative quantification of microRNA expression levels at baseline in women with chronic compared with episodic migraine. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx

  2. Subgroup analyses

    Time frame: 3 months per each patient

    Subgroup analyses of patients stratified according to age, migraine characteristics, response to erenumab, and migraine-related impact and disability. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Collaborators

  • Novartis

Registry information

Official study title

MicroRNA Profile in Women With Migraine Before and After Treatment With Erenumab

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 9, 2020
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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