TRIUMPH: Treatment of Migraine Outcomes for Patients in Real-World Healthcare Systems

Rationale and Background: Monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or the CGRP receptor have recently demonstrated to be efficacious in clinical trials in the prevention of migraine, with galcanezumab, erenumab and fremanezumab.

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 is between galcanezumab and oral standard of care. However, patients who are initiating other CGRP monoclonal agents or botulinum toxin A or B will also be eligible to participate in the study and are included in the descriptive and statistical comparisons as sample sizes permit.

Study Design: Prospective, multicenter, international, 2-stage non-interventional study. Stage 1 is a cross-sectional single day assessment which can be office, phone or web-based. 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:

Post-baseline visits will occur at Months 3, 6, 12, 18 and 24 and can be office, phone or web based. Additional office visits are allowed as this is an observational study

Patients will enter headache information into a personal electronic device each time they experience a headache throughout the longitudinal assessment.

Healthcare resource utilization will be collected monthly via personal electronic device.

Population: Adult patients with migraine who are switching or initiating new preventive treatment in clinical practice settings in multiple countries.

Principal Investigators: Dr. David Podwall
Link for more information: https://www.prnewswire.com/news-releases/lilly-announces-the-launch-of-triumph-the-first-long-term-real-world-evidence-study-of-emgality-galcanezumab-gnlm-300976517.html