Trial reportNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2025
The second interim analysis of Italian participants enrolled in the real-world, Pan-European, prospective, observational, Phase 4 PEARL study of fremanezumab effectiveness.
Trial report in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 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.
- Glatiramer acetate versus interferon β-1a: rethinking first-line therapy in pediatric-onset multiple sclerosis for greater relapse control.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
introductionMigraine burden encompasses social, economic, and functional burden; most notably in individuals with either chronic or high-frequency episodic migraine (CM, HFEM). This second interim sub-analysis of Italian participants with CM and HFEM enrolled in the PEARL study provides updated real-world evidence of fremanezumab use in Italian clinical practice for up to 12 months of treatment.
methodsIn this second interim sub-analysis, data were collected from a sub-population of participants enrolled in PEARL who were treated in Italian headache centers and had completed 12 months of fremanezumab treatment (data cut-off: 15 June 2023). The primary endpoint was the proportion of participants achieving a ≥ 50% reduction in monthly migraine days (MMD) during the 6-month period after fremanezumab initiation. Additional endpoints were assessed up to Month 12 and included mean change from baseline in average MMD. Safety was assessed through adverse events (AEs) reported.
resultsOverall, 343/354 participants enrolled in Italian headache centers (HFEM, 36.2%; CM, 63.8%) were included in the effectiveness analysis. Of those with data available, 61.2% of participants achieved a ≥ 50% reduction in average MMD during the 6-month period after fremanezumab initiation. Mean change from baseline (± standard deviation [SD]) in average MMD was - 8.2 ± 7.4 at Month 1 and - 8.9 ± 6.9 at Month 12. No new safety signals were observed.
conclusionFremanezumab was effective and well tolerated in Italian clinical practice, with results in line with those previously reported for fremanezumab in a real-world setting.
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Registered trials
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