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NCT Number: NCT07159750

Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Chronic Migraine, Headache Episodic Migraine Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FLENI, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CGRP antibody or gepant

Drug

Patients will start anti-CGRP or its receptor antibody or gepants

Primary outcomes

  1. Change in Monthly Headache Days and Monthly Migraine Days

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. HIT-6

    Time frame: Through study completion, an average of 2 years

    Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact.

  2. 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.

  3. 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.

  4. BAI

    Time frame: Through study completion, an average of 2 years.

    Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients.

  5. 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.

  6. 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.

  7. 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.

  8. ISI

    Time frame: Through study completion, an average of 2 years.

    Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients.

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edoardo Caronna, MD, PhD

CONTACT

[email protected]

(+34) 93 489 30 00 ext. 2479

Patricia Pozo-Rosich, MD, PhD

CONTACT

[email protected]

(+34) 93 489 30 00 ext. 2479

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Acronym: EUREkA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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