CompletedNot Applicable

Long-term Atogepant in Real-world Practice

Spain513 participantsStarted 2024-06-01

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in monthly headache days (MHD)

Timeframe: From baseline (initiation of atogepant treatment) to 12 months of follow-up.

Change from baseline in monthly migraine days (MMD).

Timeframe: 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.

Timeframe: From baseline (initiation of atogepant treatment) to 12 months of follow-up.

Persistence of treatment response

Timeframe: From baseline (initiation of atogepant treatment) to 12 months of follow-up.

Trial details

NCT IDNCT07699549

SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Migraine trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline in monthly headache days (MHD)

Timeframe: From baseline (initiation of atogepant treatment) to 12 months of follow-up.

Change from baseline in monthly migraine days (MMD).

Timeframe: 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.

Timeframe: From baseline (initiation of atogepant treatment) to 12 months of follow-up.

Persistence of treatment response

Timeframe: From baseline (initiation of atogepant treatment) to 12 months of follow-up.