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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  GALCANEZUMAB

  METOPROLOL

  ATENOLOL

  PROPRANOLOL HYDROCHLORIDE

  AMITRIPTYLINE

  FLUNARIZINE

  BOTULINUM TOXIN TYPE A

  BOTULINUM TOXIN TYPE B

  ERENUMAB

  FREMANEZUMAB

  TOPIRAMATE
• Medical condition to be studied:
  Migraine

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2850

Study design details

• Main study objective:
  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.
• Outcomes:
  Compare the effectiveness of galcanezumab to oral migraine preventive standard of care overall in adult patients with migraine who are switching or initiating preventive treatment. Specifically, this will estimate the proportion of patients in the longitudinal follow-up who achieve a clinically meaningful reduction from baseline in monthly migraine headache days at Month 3. Compare the long-term, real-world effectiveness of galcanezumab to other migraine preventive treatments on a variety of outcomes including, but not limited to, migraine headache day reduction, responder rates, discontinuation rates, patient-reported outcomes, acute and preventive treatment patterns and outcomes, disease and economic burden.
• Data analysis plan:
  The primary analysis aims to estimate the causal effect of galcanezumab versus oral migraine preventive standard of care when controlling for selection bias and measured confounders. The primary analysis will be performed using propensity score greedy match to assess the differences in outcome between 2 groups. Descriptive summary statistics will be presented at different time points for different treatments and treatment groups and drug classes or individually based on the sample sizes available overall and by countries using treatment as time varying.The secondary objectives for the longitudinal follow-up are to compare the effectiveness of galcanezumab to other migraine preventive treatments on outcomes. The secondary analyses will be performed using MSM, which are multi-step estimation procedure designed to control for the effect of confounding variables that change over time, and are affected by previous treatment.