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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000091
• EU PAS number:
  EUPAS45442
• Study ID:
  1000000091
• Official title and acronym:
  Real-World Observational Study to Assess Drug Utilisation Patterns in the US Among Migraine Patients Treated with Lasmiditan (H8H-MC-B005)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort database study evaluating real-world utilization patterns among patients treated with lasmiditan in the US using IBM® MarketScan commercial administrative claims. This study will describe real-world utilization patterns for patients treated with lasmiditan and patient characteristics including demographics, comorbidities, and concomitant medication use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Actual: 02/02/2022

Study start date

Planned: 31/01/2022

Actual: 22/05/2023

Date of final study report

Planned: 31/12/2023

Actual: 18/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B005 05 Protocol PASS(v0.1)_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)