Open AccessPEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine
Author(s) -
Messoud Ashina,
Faisal Mohammad Amin,
Pinar Kokturk,
Joshua M. Cohen,
Martijn Konings,
Cristina Tassorelli,
Leonidas Lyras,
DimosDimitrios Mitsikostas
Publication year - 2021
Publication title -
pain management
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.402
H-Index - 21
eISSN - 1758-1877
pISSN - 1758-1869
DOI - 10.2217/pmt-2021-0015
Subject(s) - medicine , migraine , chronic migraine , calcitonin gene related peptide , pearl , observational study , receptor , neuropeptide , philosophy , theology
Fremanezumab is a humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide and is approved in Europe for migraine prevention in adults with ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month, prospective, observational study of fremanezumab in chronic or episodic migraine. End points include proportion of patients with ≥50% reduction in monthly migraine days during 6 months of treatment (primary); changes in monthly migraine days, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another calcitonin gene-related peptide pathway-targeting monoclonal antibody. PEARL is being conducted in approximately 100 centers in 11 European countries (estimated n = 1100). PEARL will generate important real-world data on effectiveness of fremanezumab and treatment patterns in patients with chronic migraine or episodic migraine.