CORNERSTONE
Research type
Research Study
Full title
CORNERSTONE: A ProspeCtive ObseRvatioNal Study of Atogepant Effectiveness in Routine Clinical Practice
IRAS ID
350461
Contact name
Fayyaz Ahmed
Contact email
Sponsor organisation
AbbVie
Clinicaltrials.gov Identifier
NCT06543914, Clinicaltrials.gov
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Migraine is a disease characterised by recurrent and often very painful headaches. It affects more than one billion people each year across the world and often comes with other symptoms like feeling sick, being sick, and sensitivity to light or sound. There are different medications available to treat migraine. Some are taken when a migraine attack occurs to treat the symptoms, and others are taken to prevent migraine attacks. Atogepant is a preventative treatment for migraine which can reduce the frequency and symptoms of migraines.
This study aims to collect information that will help healthcare professionals understand how well atogepant works to stop migraines when it is used as part of normal practice.
This study will collect data from up to 100 adult patients with migraine in multiple hospitals. To be involved in the study, patients must be being treated with atogepant and their doctor must have made the decision to prescribe this as part of their normal practice, and not so the patient could take part in this study.
Data will be collected at eight timepoints across a period of 22 months. Healthcare professionals will gather data including patient demographics, medical history, migraine history, vital signs and medications including atogepant dose at different times through the 22 months from the patients’ medical records.
At the same time, patients will complete surveys on a smartphone or tablet to capture patient-reported outcomes through validated measures including Headache Impact Test-6, Migraine Specific Quality of Life Questionnaire, Migraine Interictal Burden Scale-4, PROMIS Cognitive Function and Cognitive Function Abilities Subset item banks and the Work Productivity and Activity Impairment Questionnaire: Migraine. Information that cannot reveal the patient's identity will be collected, and this will be anonymised in the final database.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0025
Date of REC Opinion
30 Jan 2025
REC opinion
Favourable Opinion