Detaillierte Beitrags-Information
| Beitragstitel | Design of the ContemporAry ProspecTive Understanding of Migraine Real-world Evidence (CAPTURE) Study |
|---|---|
| Beitragscode | P13 |
| Autor:innen | |
| Präsentationsform | Poster |
| Themengebiete |
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| Abstract-Text |
Background: Insufficient longitudinal evidence is available describing the impact of migraine. This global study will assess how headache/migraine frequency, disability, and treatment patterns change over a 2-year period in individuals being treated for migraine. Material and Methods: ContemporAry ProspecTive Understanding of Migraine Real-world Evidence Study (CAPTURE) is a 2-year, global, observational, longitudinal, prospective study that will enroll individuals ≥ 18 years of age being treated for migraine. Participants will be stratified into 3 baseline monthly headache day (MHD) cohorts: 4-7 days; 8-14 days; ≥ 15 days. Eligibility criteria include men/women diagnosed with migraine for >=1 year, ≤ 50 years of age at migraine onset, taking >=1 migraine medication, and a history of ≥ 4 MHDs in the 3 months prior to screening, which was confirmed prospectively with headache e-diary data in the 30-day screening period. Key study design elements and endpoints are depicted in the Figure and Table. Results: The target enrolled sample size is approximately 2000 (cohort 1: 30% [n=600]; cohorts 2-3: 35% [n=700 each]). Patients will be enrolled from approximately 135 sites in 15 countries. The target for first patient enrollment is early 2023 and the last patient completion is anticipated to be late 2025. The study will collect clinical outcomes, patient-reported outcomes, and changes in the number of patients among the migraine cohorts. Only the methodology of this study will be described. Conclusion: CAPTURE will provide a better understanding of headache/migraine frequency, disability, and treatment patterns in individuals being treated for migraine and will be one of the first global prospective longitudinal studies of its kind. |