Real-World Observational Study Using US Pharmacy Claims Data to Assess Safety Outcomes and Treatment Patterns in the US Among Migraine Patients Treated with REYVOW (Lasmiditan) Long Term (H8H-MC-B010)

Study type

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

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LASMIDITAN
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CC08) lasmiditan

  lasmiditan
• 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:
  100

Study design details

• Main study objective:
  Assess utilization and safety outcomes among patients treated with lasmiditan long term, and describe patient demographics and clinical characteristics and treatment patterns of lasmiditan treated patients treated long term
• Outcomes:
  Cardiovascular adverse events, malignancy, serotonin syndrome, and all other diagnoses identified utilizing AHRQ CCSR groupings
• Data analysis plan:
  All patients who fulfil the study selection criteria will be included. Study findings will be described as well as a summary of the literature to provide context. A flow diagram illustrating the selection of the study population will be presented. Analyses for safety outcomes will include all data up to the end of insurance coverage, end of study period, or death, upon which patients will be censored. Analyses for utilization will go through final treatment episode, end of insurance coverage, end of study period, or death, whichever occurs first.