Chronic migraine MedDRA version: 21.1 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Aimovig
Product Name: Erenumab
Pharmaceutical Form: Injection
INN or Proposed INN: ERENUMAB
CAS Number: 1582205-90-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Fundació Hospital Universitari Vall d' Hebrón - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults between 30 and 50 years of age - Mediterranean ethnicity - Patients diagnosed with high-frequent episodic and chronic migraine with or without aura, confirmed by a neurologist according to the International Classification of Headache Disorders, 3rd edition, beta version (ICHD-3 beta) that require prevention - Healthy controls will be recruited among hospital staff and non-related acquaintances of the patients that denied past or first-degree familial history of any recurrent primary or secondary headache disorder. 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 94 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease) - Evidence of drug, smoking or alcohol abuse or dependence within 12 months prior to V1, based on medical records or patient self-report. An alcohol consumption >100mg/week will be considered an abuse. - Pregnant or nursing (lactating) women - Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing with study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: SYNCHRO’s main objective is to elucidate and describe how blocking CGRP in the periphery can modulate the brain in migraine measuring anatomic and neurophysiological changes;Secondary Objective: 1. To characterize changes in brain morphometric measures and sensory/cognitive processes in migraine within the interictal period at neuroanatomic and neurophysiological level. 2. To characterize changes in brain morphometric measures and sensory/cognitive responses in non-migraine subjects at neuroanatomic and neurophysiological level. 3. To describe the impact of erenumab in adaptive sensory/cognitive processes. 4. To link the modulation of sensory/cognitive processes with the clinical efficacy of erenumab, finding predictors or response and impact on daily life.;Primary end point(s): Measure changes in cortical thickness, grey matter volumes and network connectivity (measured structurally) in migraine within the interictal period evaluated by MRI in migraine after administration of erenumab;Timepoint(s) of evaluation of this end point: On the seventh month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Determine a quantitative threshold between migraine and non-migraine subjects in their sensory/cognitive outputs using cognitive and attention measurement tasks evaluated by ERP studies.- Evaluate changes in the threshold after the effect of erenumab between treated patients and non-migraine subjects at sensory/cognitive levels - Identify clinical features, neuroanatomic measures and neurophysiological factors to predict response to treatment.;Timepoint(s) of evaluation of this end point: In the sixth month | — |
Countries
Spain
Contacts
Public ContactPatricia Pozo Rosich
Fundació Hospital Universitari Vall d' Hebrón - Institut de Recerca (VHIR)
Outcome results
None listed