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

8 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

513

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Migraine cohort
Adult patients with migraine initiating atogepant for preventive treatment in routine clinical practice across 15 tertiary Headache Units in Spain.
Droga: 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.
Altri nomi:
  • Aquipta
  • Atogepant
Altro: Headache diary
Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in monthly headache days (MHD)
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Characterization of sustained, late, and ultra-late treatment response
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2024

Completamento primario (Effettivo)

1 marzo 2026

Completamento dello studio (Effettivo)

1 marzo 2026

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5600

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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