MigrainePRACTICENCT07690215
Study to Assess Effectiveness of Oral Atogepant in Adult Participants For Prevention of Migraine in the United Kingdom
An observational study of Migraine, run by AbbVie.
Trial summary
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the effectiveness of atogepant for the preventive treatment of migraine in adult patients in the UK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 (EM) or chronic migraine (CM), who are to be treated preventative with atogepant.
Who may be able to join
- Physician-confirmed diagnosis of migraine, classified as either episodic or chronic.
- Have at least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders 3rd edition (ICHD-3), 2018.
- Without prior exposure to atogepant who are being prescribed atogepant in primary care for the prophylaxis of migraine with at least 4 migraine days per month.
- Decision to initiate atogepant was made by a prescribing general practitioner (GP) or appropriate primary care health care professional (HCP) within a primary care setting, prior to and independent of any decision to approach the patient regarding participation in the study.
- Willing and able to comply with the requirements of the study, including being able to read and comprehend written English at a level sufficient to understand and complete study patient-reported outcomes (PROs).
- Not on concomitant preventive medication for migraine or have been on a stable preventive medication for migraine for at least 3 months prior to enrolment.
- Access to a suitable device (e.g., laptop, tablet, or smartphone) to complete PRO measures.
Who cannot join
- Previously exposed to atogepant as routine therapy before the study period or from clinical trials experience prior to entry.
- Enrolled in any interventional studies that may include investigational compounds for migraine.
- Initiated on atogepant in secondary care and subsequently maintained in primary care.
- Initiated on atogepant in primary care following specialist input via an 'advice and guidance' pathway.
- Contraindications to atogepant administration as per local labelling.
- Pregnant or planning to be pregnant or women of childbearing potential not using contraception.
- In the opinion of the prescribing GP or appropriate primary care HCP, the patient has a history or current evidence of any condition that might interfere with the patient's ability to comply with the study requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient-Reported Outcomes and Healthcare Resource Use in Patients Initiated With Atogepant in a Primary Care Setting for the Prevention of Migraine: An Ambi-spective Real-World Study in the UK (PRACTICE)
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the effectiveness of atogepant for the preventive treatment of migraine in adult patients in the UK.
Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 200 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in the UK.
Read more
Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 48.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Read the detailed description
This is an ambispective study and will collect both retrospective and prospective data.
- Conditions
- Migraine
- Keywords
- Migraine, Chronic Migraine, Episodic Migraine, Atogepant, Aquipta
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atogepant | Participants will receive atogepant as prescribed by their physician according to the local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Following Atogepant Initiation As Assessed by Patient's Global Impression of Change (PGI-C)
PGI-C is a single item questionnaire used to measure the patient's impression of overall change in migraine since the first dose of atogepant. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse".
Measured: Up to approximately 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690215
- Sponsor's protocol ID
- P26-271
- Acronym
- PRACTICE
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes and Healthcare Resource Use in Patients Initiated With Atogepant in a Primary Care Setting for the Prevention of Migraine: An Ambi-spective Real-World Study in the UK (PRACTICE)
- ClinicalTrials.gov ID
- NCT07690215
- Acronym / sponsor ID
- PRACTICE / P26-271
- Conditions
- Migraine
- Keywords
- Migraine, Chronic Migraine, Episodic Migraine, Atogepant, Aquipta
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 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.
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the effectiveness of atogepant for the preventive treatment of migraine in adult patients in the UK.
Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 200 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in the UK.
Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 48.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Detailed description
This is an ambispective study and will collect both retrospective and prospective data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atogepant | – | –Participants will receive atogepant as prescribed by their physician according to the local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with (EM) or chronic migraine (CM), who are to be treated preventative with atogepant.
Key inclusion criteria (7 listed)
- Physician-confirmed diagnosis of migraine, classified as either episodic or chronic.
- Have at least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders 3rd edition (ICHD-3), 2018.
- Without prior exposure to atogepant who are being prescribed atogepant in primary care for the prophylaxis of migraine with at least 4 migraine days per month.
- Decision to initiate atogepant was made by a prescribing general practitioner (GP) or appropriate primary care health care professional (HCP) within a primary care setting, prior to and independent of any decision to approach the patient regarding participation in the study.
- Willing and able to comply with the requirements of the study, including being able to read and comprehend written English at a level sufficient to understand and complete study patient-reported outcomes (PROs).
Key exclusion criteria (7 listed)
- Previously exposed to atogepant as routine therapy before the study period or from clinical trials experience prior to entry.
- Enrolled in any interventional studies that may include investigational compounds for migraine.
- Initiated on atogepant in secondary care and subsequently maintained in primary care.
- Initiated on atogepant in primary care following specialist input via an 'advice and guidance' pathway.
- Contraindications to atogepant administration as per local labelling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Following Atogepant Initiation As Assessed by Patient's Global Impression of Change (PGI-C)
Time frame: Up to approximately 12 Weeks
PGI-C is a single item questionnaire used to measure the patient's impression of overall change in migraine since the first dose of atogepant. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
ABBVIE INC. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by AbbVie.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AbbVie Ltd (+44 (0) 1628 561090, ukmedinfo@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Following Atogepant Initiation As Assessed by Patient's Global Impression of Change (PGI-C) (time frame: Up to approximately 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.