Real-World Observational Study to Assess Drug Utilisation Patterns in the US Among Migraine Patients Treated with Lasmiditan (H8H-MC-B005)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  RAYVOW
• 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:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Main study objective:
  This study aimed to describe utilization patterns in the US for patients treated with lasmiditan in ; routine clinical practice using administrative claims data. ; The primary objectives of this study are to: describe real-world utilization of lasmiditan using prescription data over a period of 3 years after market availability to identify potential patterns of drug misuse or abuse; identify patients treated for longer than 1 year and describe treatment patterns; assess off-label treatment with lasmiditan among paediatric and adolescent patients with migraine, and; describe characteristics of lasmiditan-treated patients, including patients treated beyond 1year.
• Outcomes:
  Misuse/abuse, off-label treatment in pediatric & adolescent patients, drug-utilization characteristics
• Data analysis plan:
  All data will be summarized using descriptive statistics. Categorical variables will be presented using percentages and frequencies. Continuous variables will be presented as means and medians with associated standard deviations.

Documents

Study report

LY573144 B005 Noninterventional PASS Final Study Report – Basic Version 1_Redacted.pdf