Background
Calcitonin gene-related peptide (CGRP) is crucial in migraine pathophysiology. Eptinezumab, an intravenous (IV) anti-CGRP monoclonal antibody, was evaluated for its potential in preventing chronic migraine.
Objective
The study aimed to assess the safety, tolerability, and effectiveness of four eptinezumab dose levels to inform the phase 3 development program.
Methods
This phase 2b trial was a parallel-group, double-blind, randomized, placebo-controlled, dose-ranging clinical trial involving 616 men and women aged 18-55 years with chronic migraine. Participants had to have a history of chronic migraine for at least one year, with onset at age 35 or younger, and recorded at least 15 headache days, including 8 migraine days, during a 28-day screening period. Patients were randomly assigned to receive eptinezumab 300, 100, 30, 10 mg, or placebo as a single IV infusion.
Results
The primary endpoint was the percentage of patients achieving a ≥75% reduction in monthly migraine days over weeks 1-12 compared to the screening period. The responder rates for eptinezumab doses were 33.3% (300 mg), 31.4% (100 mg), 28.2% (30 mg), and 26.8% (10 mg), versus 20.7% for placebo. Secondary endpoints also favored the higher eptinezumab doses over placebo. The treatment was well tolerated, with adverse event rates similar to placebo.
Conclusions
The trial results indicate that eptinezumab is effective and well-tolerated for the preventive treatment of chronic migraine, supporting the justification for pivotal phase 3 trials in migraine prevention.
