MicroRNA Profile and Erenumab Treatment

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659226
• Other study ID #: CAMG334AIT05T
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Genetic:
• Blood sampling for microRNA testing
Blood samples will be collected and analyzed for the microRNA profile by means of microfluidic cards

Locations

Country	Name	City	State
Italy	University of L'Aquila	L'Aquila

Sponsors (2)

Lead Sponsor	Collaborator
University of L'Aquila	Novartis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Baseline comparison between episodic and chronic migraine	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	Baseline
Secondary	Subgroup analyses	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	3 months per each patient