Eptinezumab versus conventional preventive treatments as ≥2nd line prophylaxis of migraine – propensity score matched multiple cohort comparative retrospective longitudinal analyses of depersonalized 6-months real-world data of the German Pain e-Registry. (ESCAPE)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post-marketing, open-label, retrospective parallel-group, flexible-dose, comparative longitudinal 24-week multiple-cohort-study

Study drug and medical condition

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

  METOPROLOL

  AMITRIPTYLINE

  FLUNARIZINE

  TOPIRAMATE

  EPTINEZUMAB
• Medical condition to be studied:
  Migraine

Population studied

• Short description of the study population:
  Adult patients treated with eptinezumab versus conventional preventive treatment as ≥2nd line prophylaxis for migraine identified from the German Pain e-Registry (GPeR).
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Migraine patients
• Estimated number of subjects:
  4440

Study design details

• Main study objective:
  The main objective of this study is the evaluation of the 24-week efficacy and tolerability of eptinezumab vs. traditional prophylactics in comparable populations of migraine patients who participated in the German Pain e-Registry (GPeR).
• Outcomes:
  Primary endpoint is the 24-week response rate (i.e. no treatment discontinuation in response or as a consequence of adverse drug reactions plus a reduction of monthly migraine days ?50% in month 4-6 of the evaluation period with medication vs month -3 to -1 prior baseline). Percentage of patients who reported vs. baseline a) a reduction of monthly migraine days with acute medication ?50%, b) a reduction of migraine-related sick leave days ?50%, c) a reduction of the migraine disability assessment score ?50%, d) a reduction of migraine-related disability in daily life ?50%, e) etc.
• Data analysis plan:
  Data analyses will follow a modified intent-to-treat (ITT) approach as any data of patients who (a) take/record at least one dose of the treatments under evaluation and (b) record at least one post-baseline/post-dose measure within the defined 24-week evaluation frame will be evaluated. When changes from baseline to endpoint will be assessed, data will be included in the analysis only if there is a baseline and a corresponding postbaseline measure. All outcomes will be summarized descriptively for baseline and end-of-evaluation timepoint, and absolute and relative change from baseline using appropriate summary statistics and/or frequency distributions. Safety analyses will be conducted on the safety analysis set. All statistical tests will be carried out using a 2-sided significance level of 0.05. Test results will be presented as concrete p scores down to a level of 0.001, lower p scores will be expressed as "?0.001".