DRUG
CGRP antibody or gepant
Patients will start anti-CGRP or its receptor antibody or gepants
Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
Status
Recruiting
Phase
Not applicable
Enrollment
700
Locations
26
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 8, 2025
Study start
Jan 2, 2024
Primary completion
Jan 2026
Study completion
Jan 2026
Results posted
Not reported
Registry updated
Sep 8, 2025
Outcomes
What the study measures.
Primary outcomes
Change in Monthly Headache Days and Monthly Migraine Days
Time frame · Through study completion, an average of 2 years
Secondary outcomes
HIT-6
Time frame · Through study completion, an average of 2 years
Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact.
MIDAS
Time frame · Through study completion, an average of 2 years
Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine.
PGIC
Time frame · Through study completion, an average of 2 years.
PGIC (Patien Global Impression of Change) scale will be used to assess impression of change in migraine patients.
BAI
Time frame · Through study completion, an average of 2 years.
Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients.
BDI-II
Time frame · Through study completion, an average of 2 years.
Change in BDI-II (Beck's Depression Inventory, 2nd version) scale, to assess depression in migraine patients.
MSQ Version 2.1
Time frame · Through study completion, an average of 2 years.
Changes in MSQ (Migraine-Specific Quality-of-Life) Version 2.1 scale, to assess patient's quality of life.
WPAI
Time frame · Through study completion, an average of 2 years.
Changes in WPAI (Work Productivity and Activity Impairment) questionnaire, to assess how migraine impacts in work and productivity in migraine patients.
ISI
Time frame · Through study completion, an average of 2 years.
Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients.
ASC-12
Time frame · Through study completion, an average of 2 years.
Changes in ASC-12 (Allodynia Symptom Checklist) scale, to assess allodynia in migraine patients.
m-TOQ
Time frame · Through study completion, an average of 2 years.
m-TOQ (Migraine Treatment Optimization Questionnaire) scale will be used to assess the effectiveness of migraine treatment.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
26 registered sites.
Argentina · Chile · Colombia · Croatia · Germany · Italy · Malaysia · Norway · Poland · Portugal · Spain · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Miami, Miller School of Medicine
Miami, Florida, United States
FLENI
Buenos Aires, Argentina
Pontificia Universidad Católica de Chile
Santiago, Chile
Neuromedica
Medellín, Colombia
Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno
Rovinj, Croatia
Charité Universitätsmedizin Berlin
Berlin, Germany
LMU University Hospital
München, Germany
University of L'Aquila
L’Aquila, Italy
University of Modena and Reggio Emilia
Modena, Italy
National Neurological Institute C. Mondino Foundation
Pavia, Italy
IRCCS San Raffaele
Roma, Italy
Universiti Putra Malaysia
Serdang, Selangor, Malaysia
Neuroclinic Norway
Lillestrøm, Norway
Wrocław Medical University
Wroclaw, Poland
Hospital Santa Maria Lisbon
Lisbon, Portugal
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Vall d'Hebron University Hospital
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Fundació Sanitària Mollet
Mollet del Vallès, Barcelona, Spain
Hospital de Viladecans
Viladecans, Barcelona, Spain
Hospital General Universitario de Albacete
Albacete, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
La Paz University Hospital
Madrid, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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