Trial reportHeadache2025
Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine.
Trial report in Headache, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
objectiveThe primary objective was to characterize the pharmacokinetics (PK) and safety of eptinezumab in children and adolescents with migraine.
backgroundMigraine 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.
methodsIn 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; AUC
resultsA total of 28 participants (12 children [aged 6-11 years] and 16 adolescents [aged 12-17 years]) were enrolled in the trial, with 23 continuing into the extension period. A single intravenous administration of eptinezumab at 150 mg or 300 mg resulted in similar mean plasma concentration-time curves (mean AUC
conclusionThe PK profile in children and adolescents was consistent across different dose levels and weight groups. These results support the use of weight-based eptinezumab dosing in children and adolescents with migraine. Eptinezumab was generally well tolerated, with no new safety signals observed in this population relative to those observed in adults.
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