Episodic or chronic migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Aimovig
Product Code: [AMG334]
Pharmaceutical Form: Solution for injection in pre-filled pen
CAS Number: 1582205-90-0
Current Sponsor code: AMG334
Concentration unit: 1X 100 milligrams/m
Sponsors
ASL 1 AVEZZANO-SULMONA-L'AQUILA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in this study must meet all of the following criteria: 1. Women aged 25 to 50 years 2. Provided informed consent 3. EM or CM migraine with or without aura 4. At least 1 year from migraine onset 5. Clinical indication to treatment with erenumab according to the Summary of Product Characteristics and local reimbursement criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible for inclusion in this study. 1. Headache other than migraine 2. Prior exposure to erenumab or other monoclonal antibodies targeting CGRP or its receptor 3. 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 4. Pregnant or nursing 5. Body Mass Index 30 Kg/m2 6. Heavy smoking (more than 20 cigarettes per day) 7. Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedures within 12 months prior to first visit 8. Illicit drug abuse 9. Major psychiatric disorders 10. Infective or inflammatory diseases 11. Preventive treatments in the last 3 months 12. Any chronic medication prescribed for indications different from migraine within 60 days before study initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate how the migraine-associated microRNA expression is modulated by treatment with erenumab.;Secondary Objective: 1) To compare the expression profile of microRNAs in patients with episodic and chronic migraine. 2) To investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, response to erenumab, and migraine-related impact and disability.;Primary end point(s): Relative quantification of circulating microRNAs expression changes in women with episodic and chronic migraine before (T0) and after a 3-month (T1) treatment with erenumab.;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Relative expression profiling of selected microRNAs at baseline in women with chronic migraine compared with episodic migraine; Subgroup analysis of primary endpoint stratified according to age, migraine characteristics, response to erenumab, migraine impact and related disability;Timepoint(s) of evaluation of this end point: 3 months; 3 months | — |
Countries
Italy
Contacts
Public ContactUnità Operativa Complessa di Neurol
ASL 1 Avezzano-Sulmona-L'Aquila
Outcome results
None listed