Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine
Abstract
Objective: The primary objective was to characterize the pharmacokinetics (PK) and safety of eptinezumab in children and adolescents with migraine.
Background: Migraine in children and adolescents is a prevalent and potentially debilitating disease, and few preventive therapies are approved for use in these populations. Eptinezumab, a calcitonin gene-related peptide monoclonal antibody approved for migraine prevention in adults, has demonstrated efficacy at doses of 100 mg or 300 mg administered intravenously every 12 weeks. Defining the appropriate dosing of eptinezumab in children and adolescents is required to accurately examine the safety and efficacy of its use as a preventive migraine therapy.
Methods: In this open-label PK clinical trial conducted between August 2020 and October 2022, children and adolescents with migraine (aged 6-17 years) received weight-adjusted intravenous eptinezumab infusions. The doses were designed to match the exposure from a 300 mg dose in adults. The trial included a 28-day screening period, a 20-week main trial period, and an optional 44-week multiple-dose extension period. Participants were dosed on Day 1 and had follow-up visits at Weeks 4, 8, 12, and 20. The extension period included three additional eptinezumab infusions every 12 weeks. Primary PK endpoints included area under the curve (from zero to infinity; AUC0-inf) of eptinezumab and maximum concentration (Cmax). The effect of eptinezumab on migraine-related disability was…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 28 participants or records.
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