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

8. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

513

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Migraine cohort
Adult patients with migraine initiating atogepant for preventive treatment in routine clinical practice across 15 tertiary Headache Units in Spain.
Lék: 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.
Ostatní jména:
  • Aquipta
  • Atogepant
Jiný: Headache diary
Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in monthly headache days (MHD)
Časové okno: 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).
Časové okno: 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.
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Characterization of sustained, late, and ultra-late treatment response
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Spolupracovníci

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

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2024

Primární dokončení (Aktuální)

1. března 2026

Dokončení studie (Aktuální)

1. března 2026

Termíny zápisu do studia

První předloženo

30. června 2026

První předloženo, které splnilo kritéria kontroly kvality

8. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 5600

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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