PEARL Study Protocol: a Real-World Study of Fremanezumab Effectiveness in Patients with Chronic or Episodic Migraine
Messoud Ashina, Faisal Mohammad Amin, Pinar Kokturk, Joshua M. Cohen, Martijn Konings, Cristina Tassorelli, Leonidas Lyras, Dimos D. Mitsikostas
Abstract
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.