Long-term Atogepant in Real-world Practice (GEMA PROJECT)
Long-term Atogepant for Treatment-resistant Migraine in Real-world Clinical Practice: 12-month Result
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Madrid
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Madrid, Madrid, Spanje, 28006
- Hospital Universitario de la Princesa
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Migraine cohort
Adult patients with migraine initiating atogepant for preventive treatment in routine clinical practice across 15 tertiary Headache Units in Spain.
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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.
Andere namen:
Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.
Patients completed standardized validated questionnaires including HIT-6, HADS, and ISI at predefined follow-up visits to assess migraine-related disability and associated comorbidities.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in monthly headache days (MHD)
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Change from baseline in monthly migraine days (MMD).
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Proportion of patients achieving ≥30%, ≥50%, ≥75%, and 100% response rates over 12 months.
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Persistence of treatment response
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Persistence of treatment response will be assessed as the proportion of patients who maintain their clinical response between Months 6 and 12.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Characterization of sustained, late, and ultra-late treatment response
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Changes in migraine-related disability - HIT-6
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Changes in psychiatric comorbidities - HADS
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Changes in migraine-related comorbidities - ISI
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Insomnia Severity Index (ISI) total score will be assessed at baseline and during follow-up in the subset of patients with available data.
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Clinical predictors of sustained response at 12 months
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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).
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Impact of prior exposure to anti-CGRP monoclonal antibodies on treatment response
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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).
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Long-term safety of atogepant
Tijdsspanne: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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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).
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From baseline (initiation of atogepant treatment) to 12 months of follow-up.
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ana Belen Gago Veiga, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- Veiligheid
- Migraine
- Hoofdpijn
- Verdraagzaamheid
- Effectiviteit
- Medicatie overmatig gebruik
- Observatie studie
- Reactie op behandeling
- Chronische migraine
- CGRP
- Veiligheid op lange termijn
- Bijwerkingen
- Prospectieve studie
- Langetermijn
- Patiëntgerapporteerde resultaten
- Behandeling weerstand
- Mmd
- Preventieve therapie
- HADEN
- Echte wereld
- Atogepant
- Migraine preventie
- Calcitonine-gen-gerelateerd peptide
- HIT-6
- Bewijs uit de echte wereld
- MHD
- Preventieve behandeling
- Studie uit de echte wereld
- Gepaneerd
- Gebroek
- Vuurvaste migraine
- anti-CGRP
- Resistant migraine
- Treatment-resistant migraine
- CGRP pathway
- Oral CGRP antagonist
- Preventive migraine therapy
- Mutlicentre study
- Long-term effectiveness
- Monthly headache days
- Monthly migraine days
- ISI
Aanvullende relevante MeSH-voorwaarden
- Drugsmisbruik
- Pijn
- Neurologische manifestaties
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Hoofdpijnaandoeningen, primair
- Hoofdpijn aandoeningen
- Middelgerelateerde aandoeningen
- Chemisch veroorzaakte aandoeningen
- Misbruik van voorgeschreven medicijnen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Overmatig gebruik van medicijnen op recept
- Migraine-stoornissen
- Hoofdpijn
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Onderzoekstechnieken
- Epidemiologische methoden
- Gegevensverzameling
- Evaluatiemechanismen voor gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Volksgezondheid
- Milieu en volksgezondheid
- Gezondheidszorg economie en organisaties
- Uitkomstbeoordeling, gezondheidszorg
- Uitkomst en procesbeoordeling, gezondheidszorg
- Enquêtes en vragenlijsten
- Gezondheidsplanning
- Enquêtes in de gezondheidszorg
- Onderzoek naar gezondheidsdiensten
- Patiëntuitkomstbeoordeling
- Atogepant
- Patiënt gerapporteerde uitkomstmaten
Andere studie-ID-nummers
- 5600
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
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