Recruiting

CGRP with Medication

Sponsor:

Hospital Universitari Vall d'Hebron Research Institute

Code:

NCT07159750

Conditions

Migraine

Episodic Migraine

Chronic Migraine, Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CGRP antibody or gepant

Study Details

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.

Conditions

Migraine

Episodic Migraine

Chronic Migraine, Headache

Study ID

NCT07159750

Start date

Jan 2, 2024

Status verified date

Aug, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

Migraine Patients

Migraine patients who initiate a CGRP-targeted treatment

Interventions

CGRP antibody or gepant

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

Primary outcome measure

  • Change in Monthly Headache Days and Monthly Migraine Days [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Patricia Pozo-Rosich, MD, PhD

(+34) 93 489 30 00cefalea@vhir.org

Edoardo Caronna, MD, PhD

(+34) 93 489 30 00cefalea@vhir.org

Locations

University of Miami, Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Teshamae S Monteith

305-243-2010tmonteith@med.miami.edu

More Information

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Last update posted

Sep 8, 2025

Last verified

Aug, 2025

Keywords

  • Migraine
  • Prevention
  • Chronic Migraine
  • Episodic Migraine
  • galcanezumab
  • erenumab
  • fremanezumab
  • eptinezumab
  • rimegepant
  • atogepant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute on 2025-09-08.