NCT07699549

Brief Summary

This prospective multicentre observational study aims to evaluate the long-term effectiveness, safety, tolerability, and treatment persistence of atogepant for migraine prevention in routine clinical practice. Adult patients with migraine initiating atogepant across 15 tertiary Headache Units in Spain are followed for 12 months. Clinical outcomes, including monthly headache days, monthly migraine days, medication overuse, adverse events, treatment discontinuation, and patient-reported outcomes in a subset of participants, are assessed at baseline and after 3, 6, and 12 months. The study also characterizes different response trajectories, including sustained, delayed, and transient responses, in a real-world population with high disease burden and multiple prior preventive treatment failures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

June 30, 2026

Last Update Submit

July 21, 2026

Conditions

MigraineHeadacheHeadache (Migraine)Migraine HeadacheMigraine DisabilityMigraine DiseaseMigraine Disorder

Keywords

MigraineAtogepantCGRPanti-CGRPGepantHeadacheLong-termPreventive treatmentReal-world evidenceReal-worldTreatment resistanceChronic migraineRefractory migraineResistant migraineTreatment-resistant migraineMedication overuseGepantsCalcitonin gene-related peptideCGRP pathwayOral CGRP antagonistPreventive migraine therapyPreventive therapyMigraine preventionReal-world studyMutlicentre studyObservational studyProspective studyLong-term effectivenessLong-term safetyTolerabilityEffectivenessSafetyAdverse eventsMonthly headache daysMHDMMDMonthly migraine daysHIT-6HADSISITreatment responsePatient-reported outcomes

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in monthly headache days (MHD)

    Monthly headache days (MHD) will be assessed at baseline and after 3, 6, and 12 months of atogepant treatment to evaluate clinical effectiveness in routine clinical practice.

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • Change from baseline in monthly migraine days (MMD).

    Monthly migraine days (MMD) will be assessed at baseline and after 3, 6, and 12 months of atogepant treatment to evaluate clinical effectiveness in routine clinical practice.

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • Proportion of patients achieving ≥30%, ≥50%, ≥75%, and 100% response rates over 12 months.

    The proportion of patients achieving ≥30%, ≥50%, ≥75%, and 100% reduction from baseline in monthly headache days (MHD) and monthly migraine days (MMD) will be assessed over 12 months.

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • Persistence of treatment response

    Persistence of treatment response will be assessed as the proportion of patients who maintain their clinical response between Months 6 and 12.

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

Secondary Outcomes (7)

  • Characterization of sustained, late, and ultra-late treatment response

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • Changes in migraine-related disability - HIT-6

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • Changes in psychiatric comorbidities - HADS

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • Changes in migraine-related comorbidities - ISI

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • Clinical predictors of sustained response at 12 months

    From baseline (initiation of atogepant treatment) to 12 months of follow-up.

  • +2 more secondary outcomes

Study Arms (1)

Migraine cohort

Adult patients with migraine initiating atogepant for preventive treatment in routine clinical practice across 15 tertiary Headache Units in Spain.

Drug: Atogepant 60 mgOther: Headache diaryOther: Patient-reported outcome measures

Interventions

Atogepant 60 mgDRUG

Atogepant was administered as preventive treatment for migraine in routine clinical practice. Treatment initiation, dose selection, dose modifications, and discontinuation were determined by the treating physician according to the approved prescribing information and routine clinical practice. As this was an observational study, no study-specific intervention or randomization was performed.

Also known as: Atogepant, Aquipta
Migraine cohort
Headache diaryOTHER

Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.

Migraine cohort
Patient-reported outcome measuresOTHER

Patients completed standardized validated questionnaires including HIT-6, HADS, and ISI at predefined follow-up visits to assess migraine-related disability and associated comorbidities.

Migraine cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with migraine, according to ICHD-3 criteria, initiating preventive treatment with atogepant in routine clinical practice were included in this prospective, multicentre, open-label observational study. No masking was applied. Patients were recruited from headache units and neurology departments across Spain: * Hospital Universitario de La Princesa * Hospital Universitario de Fuenlabrada * Fundación Jiménez Díaz-UTE * Hospital de Torrejón * Hospital Virgen del Puerto * Hospital Clínico San Carlos * Hospital Universitario 12 de Octubre * Hospital Clínico Universitario de Valladolid (IBIoVALL) * Hospital Universitario La Paz * Hospital Clínico Universitario Lozano Blesa * Hospital Universitario de Getafe * Hospital Ruber Internacional Treatment initiation with atogepant for migraine prevention was determined by the treating neurologist according to clinical practice guidelines and standard of care.

You may qualify if:

  • Adults aged ≥18 years.
  • Diagnosis of migraine with or without aura established by a headache specialist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), including both chronic and episodic migraine.
  • History of migraine of at least 1 year duration.
  • Stable preventive migraine treatment (if any) for at least the previous 3 months.
  • Normal neurological examination.
  • Fulfilment of national health system reimbursement criteria for atogepant treatment.

You may not qualify if:

  • Cognitive impairment or any other condition that, in the investigator's opinion, may prevent the patient from reliably distinguishing prodromal symptoms.
  • Presence of other active primary or secondary headache disorders, except medication overuse headache or infrequent tension-type headache.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Related Publications (1)

  • Gago-Veiga AB, Lopez-Rodriguez AB, Sanchez Jimenez M, Iglesias Rubio A, Montes N, Camina Muniz J, Dominguez Gallego M, Calle de Miguel C, Latorre G, Rodriguez-Vico J, Jaimes A, Gomez Garcia A, Urtiaga S, Gonzalez Salaices M, Dileone M, Gonzalez-Garcia N, Porta-Etessam J, Cuadrado ML, Herrero San-Martin A, Guerrero-Peral AL, Gonzalez-Osorio Y, Casas-Limon J, Sanchez-Soblechero A, Lozano-Ros A, Diaz-De-Teran J, Portocarrero-Sanchez L, Molina-Martinez FJ, Santos-Lasaosa S, Martin-Avila G, Riva E, Fernandez-Lazaro I. Atogepant for migraine in real-world clinical practice: Insights from a large multicentre study in a treatment-resistant population (GEMA project). Cephalalgia. 2026 Apr;46(4):3331024261431337. doi: 10.1177/03331024261431337. Epub 2026 Apr 1.

    PMID: 41920093BACKGROUND

MeSH Terms

Conditions

Migraine DisordersHeadachePrescription Drug Overuse

Interventions

atogepantPatient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Ana Belen Gago Veiga

    Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Headache Unit

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 13, 2026

Study Start

June 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

July 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared with other researchers. This decision is based on data protection and confidentiality requirements in accordance with applicable European and national regulations (including GDPR). Given that this is a multicentre observational study conducted in routine clinical practice, access to IPD is restricted to the study investigators for the purposes of the predefined analyses. Any potential secondary use of the dataset would only be considered in fully anonymized form and subject to prior ethical approval and compliance with applicable data protection legislation.

Locations

ES(1)