Study to Assess Effectiveness of Oral Atogepant in Adult Participants For Prevention of Migraine in the United Kingdom

NCT07690215 | Not Yet Recruiting

• 1 other identifier: P26-271
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Migraine

Keywords

Migraine; Chronic Migraine; Episodic Migraine; Atogepant; Aquipta

Outcome Measures

Primary Outcomes (1)

• 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".

  Up to approximately 12 Weeks

Study Arms (1)

Atogepant

Participants will receive atogepant as prescribed by their physician according to the local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with (EM) or chronic migraine (CM), who are to be treated preventative with atogepant.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

AbbVie Ltd

CONTACT

+44 (0) 1628 561090; ukmedinfo@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07