Status: Ongoing First registered on: 13/01/2020
Last updated on: 09/04/2020
1. Study identification
EU PAS Register NumberEUPAS33068
Official titlepreventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems [TRIUMPH]
Study title acronym15Q-MC-B004
Study typeObservational study
Brief description of the studyResearch 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research groupReal World Evidence
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Andrews
First name J. Scott
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed22/04/201921/06/2019
Start date of data collection14/02/202025/02/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report27/01/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Andrews
First name J. Scott
Address line 1Lilly Corporate Center
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States
Phone number (incl. country code)13174091786 
Alternative phone number 
Fax number (incl. country code) 
Email address andrews_jeffrey_scott@lilly.com
Public Enquiries
Title Dr 
Last name Andrews 
First name J. Scott 
Address line 1Lilly Corporate Center 
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States 
Phone number (incl. country code)13174091786 
Alternative phone number 
Fax number (incl. country code) 
Email address andrews_jeffrey_scott@lilly.com 
Top