Chronic Migraine, Headache, Episodic Migraine, Migraine
Conditions
Keywords
Migraine, Prevention, Chronic Migraine, Episodic Migraine, galcanezumab, erenumab, fremanezumab, eptinezumab, rimegepant, atogepant
Brief summary
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
DRUGCGRP antibody or gepant
Patients will start anti-CGRP or its receptor antibody or gepants
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Monthly Headache Days and Monthly Migraine Days | Through study completion, an average of 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIT-6 | Through study completion, an average of 2 years | Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact. |
| MIDAS | Through study completion, an average of 2 years | Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine. |
| PGIC | 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 | Through study completion, an average of 2 years. | Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients. |
| BDI-II | 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 | 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 | 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 | Through study completion, an average of 2 years. | Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients. |
| ASC-12 | Through study completion, an average of 2 years. | Changes in ASC-12 (Allodynia Symptom Checklist) scale, to assess allodynia in migraine patients. |
| m-TOQ | 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. |
Countries
Argentina, Chile, Colombia, Croatia, Germany, Italy, Malaysia, Norway, Poland, Portugal, Spain, Turkey (Türkiye), United States
Contacts
Primary ContactPatricia Pozo-Rosich, MD, PhD
Backup ContactEdoardo Caronna, MD, PhD
Outcome results
None listed