MIGRAINE MedDRA version: 20.0 Level: HLT Classification code 10027603 Term: Migraine headaches System Organ Class: 100000004852
Conditions
Interventions
Trade Name: AJOVY 225 mg solución inyectable en jeringa precargada
Product Name: FREMANEZUMAB
Product Code: EMEA/H/C/004833
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Pro
Sponsors
INSTITUTO DE ESTUDIOS DE CIENCIAS DE LA SALUD DE CASTILLA Y LEON
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Definite diagnosis of Migraine With Aura or Migraine Without Aura according to the International Classification of Headache Disorders, 3rd version (IHCD-3) (1). 2.Age between 18 and 65 years old. 3.Providing signed informed consent form. 4.Diagnosis of migraine before 50 years old. 5.History of migraine during at least 12 months prior to the study. 6.With eight or more migraine days per month within the last three months. 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 87 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Presence of other primary headache disorders other than infrequent tension-type headache or medication overuse headache (MOH). Participation of MOH patients will be restricted to a maximum of 50% of the total sample. 2.Prior use of Fremanezumab or another monoclonal antibody targeting CGRP or CGRP receptor. 3.Prior use of less than two or more than four preventive drugs according to the local national guidelines (34), with inadequate response after sufficient doses and enough time or lack of tolerability. 4.Any medical condition that might prevent study completion or interfere with interpretation of results. 5.History of any neurological or neurosurgical condition affecting the brain. 6.History of moderate-severe head trauma. 7.History of other chronic pain syndrome with a frequency of five or more days of pain per month. 8.Presence of daily headache 9.Pregnant or breastfeeding women. 10.Current or recent use of any other prophylactic treatment in the preceding five half-lives prior to the start. 11.Exposure to onabotulinumtoxinA in the preceding four months. 12.Any expected surgery during the study. 13.Use of opioids or barbiturates. 14.Any condition contraindicating an MRI acquisition. 15.Completing headache diary at least 80% of the time during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the presence of brain changes as evaluated with several MRI modalities in patients with migraine after the administration of Fremanezumab.;Secondary Objective: 1.To determine which brain changes after three months are associated with a higher reduction of headache days compared with baseline. 2.To determine which brain anatomical or connectivity patterns at the baseline are associated and might predict a higher reduction of headache days compared with baseline. 3.To determine if responders and non-responders at three months exhibit a different pattern of changes measured with MRI.;Primary end point(s): ?Morphometric MRI parameters change from baseline during the 12- week period after the administration of Fremanezumab. [Time Frame: baseline, week 12] Morphometric MRI parameters measure gray matter properties. These parameters are cortical curvature, cortical thickness, gray matter volume and surface area. ?Diffusion MRI descriptors change from baseline during the 12-week period after the administration of Fremanezumab. [Time Frame: baseline, week 12] Diffusion MRI descriptors describe white matter properties. These descriptors are Fractional Anisotropy, Mean Diffusivity, Radial Diffusivity and Axial Diffusivity. ?Structural connectivity change from baseline during the 12-week period after the administration of Fremanezumab. [Time Frame: baseline, week 12] Structural connectivity measures are the number of streamlines, mean Fractional Anisotropy and mean Axial Diffusivity in the connection between two regions. ?Resting-state functional connectivity change from baseline during the 12-week period after the administration of Fremanezumab. [Time Frame: baseline, week 12] Resting-state functional connectivity measure is a Z-score. clinical outcomes will be: a.Reduction in migraine days per month between weeks 8-12 compared with baseline. b.Reduction in intense headache days per month between weeks 8-12 compared with baseline. c.Reduction in ac | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Variables ?Relationship between morphometric MRI parameters and the change in monthly migraine days. [Time Frame: baseline, week 12] ?Relationship between diffusion descriptors and the change in monthly migraine days. [Time Frame: baseline, week 12] ?Relationship between structural connectivity and the change in monthly migraine days. [Time Frame: baseline, week 12] ?Relationship between resting-state functional connectivity and the change in monthly migraine days. [Time Frame: baseline, week 12] ?Baseline morphometric MRI parameters will be assessed as potential predictors of change in monthly migraine days. ?Baseline diffusion MRI descriptors will be assessed as potential predictors of change in monthly migraine headache days. ?Baseline structural connectivity will be assessed as potential predictors of change in monthly migraine days. ?Baseline resting-state functional connectivity will be assessed as potential predictors of change in monthly migraine days. ?Difference between clinical response groups in the morphometric parameters, diffusion descriptors, structural connectivity and restingstate functional connectivity. [Time Frame: baseline, week 12] Clinical response assessed as reduction by at least 50% in monthly migraine days in the last month compared to baseline. Exploratory Efficacy Variables ?Relationship between morphometric MRI parameters, diffusion descriptors, structural connectivity and resting-state functional connectivity, and the change in monthly intense headache days. [Time Frame: baseline, week 12] ?Relationship between morphometric MRI parameters, diffusion descriptors, structural connectivity and resting-state functional connectivity, and the change in days of use of acute treatment medication. [Time Frame: baseline, week 12] ?Difference between clinical response groups in the morphometric parameters, diffusion descriptors, structural connectivity and restingstate functional connectivity. [Time Fra | — |
Countries
Spain
Contacts
Public ContactICSCYL
INSTITUTO DE ESTUDIOS DE CIENCIAS DE LA SALUD DE CASTILLA Y LEON
Outcome results
None listed