NCT07699549Completed
Long-term Atogepant in Real-world Practice
Long-term Atogepant for Treatment-resistant Migraine in Real-world Clinical Practice: 12-month Result
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 513 (actual)
- First submitted
- 30 Jun 2026
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Diseases
- Migraine
- NCT number
- NCT07699549
What you commit to
- Study type: Observational
- Participants enrolled: 513
- From 1 Jun 2024 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.