Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Episodic and chronic migraine patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CGRP antibody or gepant
DrugPatients will start anti-CGRP or its receptor antibody or gepants
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: Migraine Patients1 intervention
Trial outcomes
Primary outcomes
1
Change in Monthly Headache Days and Monthly Migraine Days
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
HIT-6
Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact.
Time frame
Through study completion, an average of 2 years2
MIDAS
Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine.
Time frame
Through study completion, an average of 2 years3
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.4
BAI
Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients.
Time frame
Through study completion, an average of 2 years.Sponsors and contacts
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Source ClinicalTrials.gov