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

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)

Overview

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.

Primary outcome measures

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07690215 · P26-271

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗