Study identification

PURI

https://redirect.ema.europa.eu/resource/37094

EU PAS number

EUPAS37093

Study ID

37094

Official title and acronym

EU Population-Based Cross-Sectional Survey in Migraine: ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE (EU OVERCOME)

DARWIN EU® study

No

Study countries

Germany
Spain

Study description

This study is a non-interventional, cross-sectional observational study with data collected via a web-based survey.Research question and objectives: Describe diagnosis, barriers to treatment and pharmacological patterns, as well as non-pharmacological treatment patterns of people with migraine in Spain and Germany who meet the International Classification of Headache Disorders (ICHD)-3 criteria. Secondary objectives aim to evaluate people with migraine regarding certain co-morbidities and migraine risk factors, to understand behavior and symptom severity during their attack, and specifics of attack treatment. The impact of migraine on private and social life will also be evaluated. Furthermore, comparative analyses will be done comparing people with migraine on novel treatments with those on SOC treatments for migraine, looking how novel treatments for migraine influence various clinical, humanistic, and economic outcomes. Subgroups analyses may include comparisons according to different frequency of monthly headache days 0-3, 4-7, 8-14, ≥15.Population: This study will include adult members of a web-survey panel living in Spain and Germany, who meet inclusion and exclusion criteria and who agree to participate. Participants with migraines meeting the ICHD-3 screening criteria will be included in the migraine cohort. Those who do not meet the screening criteria may be included in the non-migraine cohort. Participants who are less than 18 years old, unwilling or unable to provide informed consent, or unable to read and write Spanish or German will be excluded from participation.Variables: Broad range of variables including demographics, health status, medication use, non-pharmacological behavioural treatments, migraine attack frequency/severity, migraine symptoms, quality of life, healthcare resource utilization, barriers to care seeking, stigmaData sources/Data Collection: Web-based survey

Study status

Planned
Research institution and networks

Institutions

Kantar Health
First published:
01/02/2024
Institution
CRO on behalf of the Sponsor: Eli Lilly & Company

Contact details

Treuer Tamas

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly & Company
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable