PRACTICE Version 1.0
Research type
Research Study
Full title
Patient-Reported outcomes and healthcare resource use in patients initiating Atogepant in a primary Care setting for the prevenTIon of migraine: an ambi-speCtive rEal-world study in the UK (PRACTICE)
IRAS ID
368275
Contact name
Ewa Kalinowska
Contact email
Sponsor organisation
AbbVie
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
Migraine is a common neurological condition that substantially affects daily functioning, productivity, and quality of life. In the United Kingdom, migraine preventive care has traditionally been delivered within secondary care; however, management is increasingly shifting to primary care to improve patient access and reduce pressure on specialist services.
Atogepant is a recently approved once‑daily oral medication, a calcitonin gene‑related peptide (CGRP) receptor antagonist for the preventive treatment of migraine. Clinical trials have demonstrated meaningful reductions in monthly migraine and headache days, alongside improvements in patient‑reported outcomes. Despite this evidence, real‑world data on the use of atogepant in UK primary care remain limited, particularly in relation to its effectiveness, impact on daily functioning and work productivity, and associated healthcare resource utilisation outside controlled trial settings.
The PRACTICE study has been designed to address this evidence gap by evaluating outcomes following initiation of atogepant when prescribed as part of routine clinical care in primary care settings. The rationale for the study is to understand how patients respond to this new preventive therapy in real‑world practice, capturing outcomes that are relevant to patients, clinicians, and healthcare commissioners. These include quality of life, daily functioning, work productivity, and patterns of healthcare utilisation.
This is an observational study incorporating retrospective data collection for up to 48 weeks prior to atogepant initiation and prospective follow‑up for up to 48 weeks after treatment begins. Atogepant is prescribed by general practitioners according to standard clinical practice, and no study‑mandated medical interventions are introduced. Participants will complete validated patient‑reported outcome questionnaires at baseline and at approximately 12, 24, and 48 weeks following treatment initiation. The study will be conducted in the United Kingdom, with approximately 150–200 adults with episodic or chronic migraine recruited from around 10 primary care centres.
REC name
Wales REC 7
REC reference
26/WA/0136
Date of REC Opinion
8 Jun 2026
REC opinion
Further Information Favourable Opinion