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Long-term Atogepant in Real-world Practice (GEMA PROJECT)

8. juli 2026 opdateret af: Ana Gago, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Long-term Atogepant for Treatment-resistant Migraine in Real-world Clinical Practice: 12-month Result

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Preventive migraine therapies targeting the calcitonin gene-related peptide (CGRP) pathway have transformed clinical practice, particularly monoclonal antibodies and, more recently, gepants. Atogepant, an oral CGRP receptor antagonist, has demonstrated efficacy and safety in randomized controlled trials and extensions across episodic, chronic, and treatment-refractory migraine populations. However, these studies are based on highly selected cohorts with limited external validity. In routine clinical practice, patients present with high disease burden, multiple preventive treatment failures, prior exposure to CGRP-targeted therapies, medication overuse, and psychiatric comorbidities, all of which may influence outcomes. Although short- and mid-term real-world data support clinically meaningful benefit within 3-6 months, evidence beyond this period remains limited, particularly regarding long-term effectiveness, tolerability, and treatment persistence, as well as sustained, delayed, or transient response trajectories.

This prospective multicentre observational study was conducted within the GEMA (GEpants in MigrAine-Atogepant) Project across 15 tertiary Headache Units in Spain. Adults with migraine initiating atogepant in routine clinical practice were consecutively enrolled between June 2024 and March 2025 and followed for 12 months. Data were collected at baseline and at 3, 6, and 12 months using standardized REDCap case report forms through structured interviews. Variables included sociodemographic and clinical characteristics, migraine phenotype, disease duration, prior preventive treatment failures, concomitant preventive therapies, monthly headache days (MHD), monthly migraine days (MMD), analgesic overuse, adverse events, and treatment discontinuation. Definitions were based on ICHD-3 criteria. In a subset, patient-reported outcomes were assessed using validated instruments: Headache Impact Test (HIT-6), Hospital Anxiety and Depression Scale (HADS), and Insomnia Severity Index (ISI). Analyses were performed using both all-available-observation and complete-case approaches, without imputation of missing outcome data.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

513

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Madrid
      • Madrid, Madrid, Spanien, 28006
        • Hospital Universitario de La Princesa

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Migraine cohort
Adult patients with migraine initiating atogepant for preventive treatment in routine clinical practice across 15 tertiary Headache Units in Spain.
Medicin: Atogepant 60 mg
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.
Andre navne:
  • Aquipta
  • Atogepant
Andet: Headache diary
Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.
Andet: Patient-reported outcome measures
Patients completed standardized validated questionnaires including HIT-6, HADS, and ISI at predefined follow-up visits to assess migraine-related disability and associated comorbidities.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in monthly headache days (MHD)
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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).
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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.
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Characterization of sustained, late, and ultra-late treatment response
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Patients will be classified as sustained, late, or ultra-late responders according to the predefined response criteria, and the proportion of patients in each response category will be assessed over 12 months.
From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in migraine-related disability - HIT-6
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Headache Impact Test-6 (HIT-6) total score will be assessed at baseline and during follow-up in the subset of patients with available data.
From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in psychiatric comorbidities - HADS
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Hospital Anxiety and Depression Scale (HADS) total score will be assessed at baseline and during follow-up in the subset of patients with available data.
From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in migraine-related comorbidities - ISI
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Insomnia Severity Index (ISI) total score will be assessed at baseline and during follow-up in the subset of patients with available data.
From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Clinical predictors of sustained response at 12 months
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Baseline clinical characteristics associated with sustained response at Month 12 will be evaluated. Sustained response will be defined as achieving a ≥50% reduction from baseline in monthly headache days (MHD) and monthly migraine days (MMD).
From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Impact of prior exposure to anti-CGRP monoclonal antibodies on treatment response
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Treatment response will be compared according to prior anti-CGRP monoclonal antibody exposure, number of prior anti-CGRP monoclonal antibodies, and prior target (ligand vs receptor).
From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Long-term safety of atogepant
Tidsramme: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Long-term safety will be assessed by recording adverse events, treatment discontinuation, and reasons for treatment discontinuation over 12 months, stratified by follow-up interval (0-3, 3-6, and 6-12 months).
From baseline (initiation of atogepant treatment) to 12 months of follow-up.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Samarbejdspartnere

Hospital General Universitario Gregorio Marañon
Hospital Son Espases
Hospital Universitario 12 de Octubre
Hospital San Carlos, Madrid
Hospital Universitario La Paz
Hospital Universitario Getafe
Hospital Universitario Fundación Alcorcón
Hospital Clínico Universitario de Valladolid
Hospital Universitario de Fuenlabrada
Hospital Clínico Universitario Lozano Blesa
Fundación Jimenez Diaz de Madrid
Hospital Virgen del Puerto
Hospital Torrejón de Ardoz

Efterforskere

  • Ledende efterforsker: Ana B Gago-Veiga, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2024

Primær færdiggørelse (Faktiske)

1. marts 2026

Studieafslutning (Faktiske)

1. marts 2026

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5600

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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