Prospective observational study of Fremanezumab (Ajovy™) effectiveness in chronic and episodic migraine patients in clinical routine: FINESSE study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Study drug and medical condition

• 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:
  1000

Study design details

• Main study objective:
  To evaluate the effectiveness of fremanezumab administered in adult patients with chronic migraine (CM) or episodic migraine (EM) who have at least 4 migraine days per month, including the proportion of patients reaching at least 50% reduction in the monthly average number of migraine days, during the 6-month period after the first dose of fremanezumab, in real-world clinical practice.
• Outcomes:
  The proportion of patients reaching at least 50% reduction in the monthly average number of migraine days during the 6-month period after the first dose of fremanezumab. Please refer to study protocol section 5.3.2. (Primary and Secondary Endpoints).
• Data analysis plan:
  All treatment period timepoints will be defined in relation to each patient’s first dose of fremanezumab, regardless of their time of enrollment. All outcomes will be reported using summary statistics. No sensitivity analyses are planned. Interim analyses are planned.