Evidence map›Paper›PMID 40938500›Full record

ArticleEpilepsia open2025

Long-term plasma monitoring of THC and CBD in pediatric drug-resistant epilepsy: Implications for cannabidiol therapy with Epidyolex®.

Alessia Cafaro, Antonella Riva, Federica Pigliasco, Sebastiano Barco, Valentina Manca, Maria Stella Vari, Maria Margherita Mancardi, Lino Nobili, Simona Pichini, Francesco Paolo Busardò and 2 more

Abstract read
In one paragraph

Article in Epilepsia open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Alessia CafaroBiochemistry, Pharmacology and Newborn Screening Unit, Central Laboratory of Analysis, IRCCS Istituto Giannina, Gaslini, Genoa, Italy.ORCID https://orcid.org/0000-0003-1132-1267
Antonella RivaDepartment of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy.
Federica PigliascoBiochemistry, Pharmacology and Newborn Screening Unit, Central Laboratory of Analysis, IRCCS Istituto Giannina, Gaslini, Genoa, Italy.ORCID https://orcid.org/0000-0002-2631-8610
Sebastiano BarcoBiochemistry, Pharmacology and Newborn Screening Unit, Central Laboratory of Analysis, IRCCS Istituto Giannina, Gaslini, Genoa, Italy.ORCID https://orcid.org/0000-0002-1148-427X
Valentina MancaDepartment of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy.
Maria Stella VariPaediatric Neurology and Muscular Disease Unit, IRCCS Istituto Giannina Gaslini, full member of ERN EpiCARE, Genoa, Italy.
Maria Margherita MancardiUnit of Child Neuropsychiatry, IRCCS Gaslini, Genoa, Italy.ORCID https://orcid.org/0000-0001-5122-4029
Lino NobiliDepartment of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy.
Simona PichiniNational Centre on Addiction and Doping, Istituto Superiore di Sanità, Rome, Italy.
Francesco Paolo BusardòDepartment of Excellence-Biomedical Sciences and Public Health, Università Politecnica delle Marche, Ancona, Italy.
Pasquale StrianoDepartment of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy.ORCID https://orcid.org/0000-0002-6065-1476
Giuliana CangemiBiochemistry, Pharmacology and Newborn Screening Unit, Central Laboratory of Analysis, IRCCS Istituto Giannina, Gaslini, Genoa, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study evaluated long-term plasma concentrations of cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) in children receiving highly purified cannabidiol (hpCBD; Epidyolex®) therapy for drug-resistant epilepsy. A retrospective analysis was performed on 38 patients with a median age of 11 years (IQR, 5) treated in a single center from 2019 to 2024. Incremental doses of Epidyolex® (mean dose: 13.6 mg/kg/day) were administered, and plasma levels of CBD and THC were measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). THC remained consistently undetectable (<0.2 μg/L) at all time points, confirming the negligible systemic exposure. CBD levels increased dose-dependently, reaching a median concentration of 89.8 μg/L (IQR, 112.2) at final follow-up, demonstrating a significant positive correlation (p < 0.0001) between dosage and plasma concentration. Epidyolex® treatment effectively maintains therapeutic CBD levels without detectable THC, supporting the safety and suitability of this therapy. These results highlight the value of plasma CBD monitoring to verify dose-dependent exposure and support safe, individualized treatment with CBD. PLAIN LANGUAGE SUMMARY: This study examined blood levels of cannabidiol (CBD) and tetrahydrocannabinol (THC) in children with drug-resistant epilepsy treated with highly purified CBD (Epidyolex). CBD levels increased proportionally with the dose, while THC levels remained undetectable. The consistent lack of THC detection across all measured time points and dose levels suggests that systemic exposure to THC remains negligible, even with prolonged administration.

Indexed as

AnticonvulsantsCannabidiolDronabinolDrug Resistant EpilepsyAdolescentChildChild, PreschoolDose-Response Relationship, DrugDrug MonitoringFemaleHumansMaleRetrospective StudiesTandem Mass SpectrometryAnticonvulsantsCannabidiolDronabinolcannabidiolcannabischildrenepilepsysafety

Identifiers

PMID40938500
PMCPMC12514384

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.