Study identification

EU PAS number

EUPAS33068

Study ID

41403

Official title and acronym

preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems [TRIUMPH] (15Q-MC-B004)

DARWIN EU® study

No

Study countries

Germany
Italy
Japan
Spain
United Arab Emirates
United Kingdom
United States

Study description

Research objectives: The overall aim is to estimate real-world effectiveness and associated outcomes, as well as describe treatment patterns, in patients with migraine in routine clinical care who are switching or initiating pharmacologic treatment for migraine prevention. The primary comparison of interest will be between galcanezumab and oral standard of care. However, patients who are initiating other CGRP antagonists or botulinum toxin A or B will also be eligible to participate in the study and included in descriptive and statistical comparisons as sample sizes permit. Design: Prospective, multicenter, international, 2-stage noninterventional study. Stage 1 is a cross-sectional, single-day assessment. Stage 2 is a 24-month longitudinal assessment. Entry into Stage 2 is dependent on which preventive treatment the patient is initiating. During Stage 2: Postbaseline visits will occur at Month 3, 6, 12, 18, 24. Additional office visits are allowed as this is an observational study. Population: Adult patients with migraine who are switching or initiating new preventive treatment in clinical practice settings in multiple countries Variables: o demographics o concomitant medications o medical history and comorbidities o migraine history, migraine treatment history, and current disease state o preventive and acute treatment use and rationale for changes o migraine headache days and headache days, headache hours, severity, and symptoms o health-related quality of life o migraine-related burden and disability o healthcare resource utilization o work productivity and activity impairment o acute treatment outcomes o symptoms of anxiety, depression, and allodynia o medication adherence, persistence, and satisfaction Size: Stage 1 will include a sufficient number of patients to achieve approx 2850 patients total entering Stage 2, with enrollment targets stratified by country.

Study status

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable