MicroRNA Profile and Erenumab Treatment

NCT04659226 | Completed

• 1 other identifier: CAMG334AIT05T
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Keywords

cgrp; monoclonal antibodies; microRNA; epigenetic; migraine prevention

Outcome Measures

Primary Outcomes (2)

• Fold changes in microRNA serum concentration - Episodic migraine

  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

  3 months per each patient

• Fold changes in microRNA serum concentration - Chronic migraine

  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

  3 months per each patient

Secondary Outcomes (2)

• Baseline comparison between episodic and chronic migraine

  Baseline

• Subgroup analyses

  3 months per each patient

Study Arms (1)

Episodic or chronic migraine

EXPERIMENTAL

Women starting treatment with erenumab according to clinical indication

Genetic: Blood sampling for microRNA testing

Interventions

Blood sampling for microRNA testing GENETIC

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

Episodic or chronic migraine

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of L'Aquila: lead
• Novartis: collaborator

Study Sites (1)

University of L'Aquila

L’Aquila, 67100, Italy

Location

Related Publications (1)

• Ornello R, Zelli V, Compagnoni C, Caponnetto V, De Matteis E, Tiseo C, Tessitore A, Sacco S. MicroRNA profiling in women with migraine: effects of CGRP-targeting treatment. J Headache Pain. 2024 May 16;25(1):80. doi: 10.1186/s10194-024-01787-2.

  PMID: 38755568 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: December 9, 2020
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)