The goal of this observational study is to evaluate clinical differences in patients who received preventive treatment with medication targeting calcitonin gene-related peptide (CGRP) or its receptor: monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) during a 2-year period observation phase.
It is a 2-year, multicenter observational study. Patients who meet reimbursement criteria according to local regulations and willing to participate in the study will be included. Monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) will be started and baseline assessment will be conducted. There will be visits every 6 months to assess effectiveness, side-effects, PROMs, and elegibility to continue with the study drug. The observation of patients will last 2 years.
Study Type
OBSERVATIONAL
Enrollment
700
Patients will start anti-CGRP or its receptor antibody or gepants
University of Miami, Miller School of Medicine
Change in Monthly Headache Days and Monthly Migraine Days
Time frame: Through study completion, an average of 2 years
HIT-6
Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact.
Time frame: Through study completion, an average of 2 years
MIDAS
Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine.
Time frame: Through study completion, an average of 2 years
PGIC
PGIC (Patien Global Impression of Change) scale will be used to assess impression of change in migraine patients.
Time frame: Through study completion, an average of 2 years.
BAI
Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients.
Time frame: Through study completion, an average of 2 years.
BDI-II
Change in BDI-II (Beck's Depression Inventory, 2nd version) scale, to assess depression in migraine patients.
Time frame: Through study completion, an average of 2 years.
MSQ Version 2.1
Changes in MSQ (Migraine-Specific Quality-of-Life) Version 2.1 scale, to assess patient's quality of life.
Time frame: Through study completion, an average of 2 years.
WPAI
Changes in WPAI (Work Productivity and Activity Impairment) questionnaire, to assess how migraine impacts in work and productivity in migraine patients.
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Miami, Florida, United States
FLENI
Buenos Aires, Argentina
RECRUITINGPontificia Universidad Católica de Chile
Santiago, Chile
RECRUITINGNeuromedica
Medellín, Colombia
RECRUITINGSpecial Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno
Rovinj, Croatia
RECRUITINGCharité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGLMU University Hospital
München, Germany
RECRUITINGUniversity of L'Aquila
L’Aquila, Italy
RECRUITINGUniversity of Modena and Reggio Emilia
Modena, Italy
RECRUITINGNational Neurological Institute C. Mondino Foundation
Pavia, Italy
RECRUITING...and 16 more locations
Time frame: Through study completion, an average of 2 years.
ISI
Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients.
Time frame: Through study completion, an average of 2 years.
ASC-12
Changes in ASC-12 (Allodynia Symptom Checklist) scale, to assess allodynia in migraine patients.
Time frame: Through study completion, an average of 2 years.
m-TOQ
m-TOQ (Migraine Treatment Optimization Questionnaire) scale will be used to assess the effectiveness of migraine treatment.
Time frame: Through study completion, an average of 2 years.