Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CGRP antibody or gepant.
- Who it may be relevant to
- Registry conditions: Migraine, Episodic Migraine, Chronic Migraine, Headache. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Chile, Colombia, Croatia +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Drug CGRP antibody or gepant
Patients will start anti-CGRP or its receptor antibody or gepants
Primary outcome measures
- Change in Monthly Headache Days and Monthly Migraine Days [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (10)
- HIT-6 [Time frame: Through study completion, an average of 2 years]
- MIDAS [Time frame: Through study completion, an average of 2 years]
- PGIC [Time frame: Through study completion, an average of 2 years.]
- BAI [Time frame: Through study completion, an average of 2 years.]
- BDI-II [Time frame: Through study completion, an average of 2 years.]
- MSQ Version 2.1 [Time frame: Through study completion, an average of 2 years.]
- WPAI [Time frame: Through study completion, an average of 2 years.]
- ISI [Time frame: Through study completion, an average of 2 years.]
- ASC-12 [Time frame: Through study completion, an average of 2 years.]
- m-TOQ [Time frame: Through study completion, an average of 2 years.]
Eligibility criteria
Inclusion criteria
- Migraine diagnosis according to ICHD-III.
- Prescription of erenumab, galcanezumab, fremanezumab, eptinezumab, atogepant or rimegepant according to prescriptor criteria and reimbursement criteria according to local regulations.
- Signature of informed consent.
Exclusion criteria
- Presence of headache different from migraine.
- Active severe psychiatric condition or cognitive impairment which may affect the ability to consent patient's participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 10 centers
- Germans Trias i Pujol Hospital — Badalona
- Vall d'Hebron University Hospital — Barcelona
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
- Fundació Sanitària Mollet — Mollet del Vallès
- Hospital de Viladecans — Viladecans
- Hospital General Universitario de Albacete — Albacete
- Fundación Jiménez Díaz — Madrid
- Hospital Universitario Gregorio Marañón — Madrid
- … and 2 more centers
Italy · 4 centers
- University of L'Aquila — L’Aquila
- University of Modena and Reggio Emilia — Modena
- National Neurological Institute C. Mondino Foundation — Pavia
- IRCCS San Raffaele — Roma
Germany · 2 centers
- Charité Universitätsmedizin Berlin — Berlin
- LMU University Hospital — München
United States · 1 center
- University of Miami, Miller School of Medicine — Miami
Argentina · 1 center
- FLENI — Buenos Aires
Chile · 1 center
- Pontificia Universidad Católica de Chile — Santiago
Colombia · 1 center
- Neuromedica — Medellín
Croatia · 1 center
- Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno — Rovinj
Malaysia · 1 center
- Universiti Putra Malaysia — Serdang
Norway · 1 center
- Neuroclinic Norway — Lillestrøm
Poland · 1 center
- Wrocław Medical University — Wroclaw
Portugal · 1 center
- Hospital Santa Maria Lisbon — Lisbon
Turkey (Türkiye) · 1 center
- Mersin University — Mersin
Identifiers
NCT: NCT07159750 · EOM(AG)008/2024(6234)