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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41403
• 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

Study timelines

Date when funding contract was signed

Planned: 22/04/2019

Actual: 21/06/2019

Study start date

Planned: 14/02/2020

Actual: 25/02/2020

Date of final study report

Planned: 27/01/2024

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