MigraineGEMA PROJECTNCT07699549
Long-term Atogepant in Real-world Practice
An observational study of Migraine and Headache, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Headache, Headache (Migraine)
- What is being tested?
- Atogepant 60 mg, Headache diary and Patient-reported outcome measures
- How many people
- 513 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to 1 Mar 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Migraine, Headache, Headache (Migraine), Migraine Disease, Migraine Disorder, Migraine Headache
- Being tested
- Atogepant 60 mg, Headache diary, Patient-reported outcome measures
- Keywords
- Migraine, Atogepant, CGRP, anti-CGRP, Gepant, Headache, Long-term, Preventive treatment, Real-world evidence, Real-world, Treatment resistance, Chronic migraine, Refractory migraine, Resistant migraine, Treatment-resistant migraine, Medication overuse, Gepants, Calcitonin gene-related peptide, CGRP pathway, Oral CGRP antagonist
- Medical subject headings
- Migraine Disorders, Headache, Prescription Drug Overuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atogepant 60 mgDrug
Also called Atogepant, Aquipta
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.
Headache diaryOther
Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.
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.
| Study group | Role | What they receive |
|---|---|---|
| Migraine cohort | Adult patients with migraine initiating atogepant for preventive treatment in routine clinical practice across 15 tertiary Headache Units in Spain. Receives: Drug: Atogepant 60 mg; Other: Headache diary; Other: Patient-reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Secondary outcomes (7)
Characterization of sustained, late, and ultra-late treatment response
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.
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in migraine-related disability - HIT-6
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.
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in psychiatric comorbidities - HADS
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.
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in migraine-related comorbidities - ISI
Insomnia Severity Index (ISI) total score will be assessed at baseline and during follow-up in the subset of patients with available data.
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Clinical predictors of sustained response at 12 months
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).
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Impact of prior exposure to anti-CGRP monoclonal antibodies on treatment response
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).
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Long-term safety of atogepant
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).
Measured: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jun 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 513 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada, Fundación Jimenez Diaz de Madrid, Hospital Virgen del Puerto, Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Clínico Universitario de Valladolid, Hospital Universitario Fundación Alcorcón, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Hospital Son Espases, Hospital Clínico Universitario Lozano Blesa, Hospital Universitario Getafe, Hospital Torrejón de Ardoz
- Responsible party
- Principal investigator, Ana Gago, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- Ana Beatriz Gago Veiga, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699549
- Sponsor's protocol ID
- 5600
- Acronym
- GEMA PROJECT
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41920093
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Atogepant for Treatment-resistant Migraine in Real-world Clinical Practice: 12-month Result
- ClinicalTrials.gov ID
- NCT07699549
- Acronym / sponsor ID
- GEMA PROJECT / 5600
- Conditions
- Migraine, Headache, Headache (Migraine), Migraine Disease, Migraine Disorder, Migraine Headache
- Keywords
- Migraine, Atogepant, CGRP, anti-CGRP, Gepant, Headache, Long-term, Preventive treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada, Fundación Jimenez Diaz de Madrid, Hospital Virgen del Puerto, Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Clínico Universitario de Valladolid, Hospital Universitario Fundación Alcorcón, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Hospital Son Espases, Hospital Clínico Universitario Lozano Blesa, Hospital Universitario Getafe, Hospital Torrejón de Ardoz
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine cohort | – | Drug: Atogepant 60 mg, Other: Headache diary, Other: Patient-reported outcome measuresAdult patients with migraine initiating atogepant for preventive treatment in routine clinical practice across 15 tertiary Headache Units in Spain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atogepant 60 mgAlso: Atogepant, AquiptaAtogepant 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. | Drug | Migraine cohort |
| Headache diaryPatients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up. | Other | Migraine cohort |
| Patient-reported outcome measuresPatients completed standardized validated questionnaires including HIT-6, HADS, and ISI at predefined follow-up visits to assess migraine-related disability and associated comorbidities. | Other | Migraine cohort |
Primary outcome
Change from baseline in monthly headache days (MHD)
Time frame: 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.
Change from baseline in monthly migraine days (MMD).
Time frame: 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.
Proportion of patients achieving ≥30%, ≥50%, ≥75%, and 100% response rates over 12 months.
Time frame: 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.
Persistence of treatment response
Time frame: 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.
7 secondary outcomes
Characterization of sustained, late, and ultra-late treatment response
Time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in migraine-related disability - HIT-6
Time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in psychiatric comorbidities - HADS
Time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Changes in migraine-related comorbidities - ISI
Time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Clinical predictors of sustained response at 12 months
Time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Impact of prior exposure to anti-CGRP monoclonal antibodies on treatment response
Time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Long-term safety of atogepant
Time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 41920093Gago-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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Beatriz Gago Veiga principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Headache, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in monthly headache days (MHD) (time frame: From baseline (initiation of atogepant treatment) to 12 months of follow-up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07699549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.