Evidence map›Paper›PMID 36537292›Full record

Trial reportPharmacology research & perspectives2023

An innovative ethosuximide granule formulation designed for pediatric use: Comparative pharmacokinetics, safety, tolerability, and palatability profile versus reference syrup.

Léonore Diezi, Kim Dao, Vincent Jullien, Caroline Roussel-Maupetit, Ingrid Burton, Pascal André, Carine Bardinet, Laura E Rothuizen, Haithem Chtioui, Maria A Manso-Silvan and 6 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pharmacology research & perspectives, 2023. 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
0.4field-weighted citation impact, top 37% of its field
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, 4 citations in OpenAlex.

  1. Trial
  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

16 authors at 4 institutions in 3 countries.

Léonore DieziClinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.ORCID 0000-0002-8305-552X
Kim DaoClinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.ORCID 0000-0002-6033-3435
Vincent JullienInserm U1129, Paris, France.
Caroline Roussel-MaupetitAdvicenne Pharma, Nîmes, France.
Ingrid BurtonClinbay, Genappe, Belgium.
Pascal AndréClinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Carine BardinetClinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Laura E RothuizenClinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Haithem ChtiouiClinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Maria A Manso-SilvanAdvicenne Pharma, Nîmes, France.
Catherine GuittetAdvicenne Pharma, Nîmes, France.
Françoise Brunner-FerberBrunner Naga, Pfaeffikon, Zürich, Switzerland.
Francois VandenhendeClinbay, Genappe, Belgium.
Catherine ChironInserm U1129, Paris, France.
Luc-André GranierAdvicenne Pharma, Nîmes, France.
Thierry BuclinClinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.ORCID 0000-0003-0639-5536
University of Lausanne · CHAdvicenne Pharma (France) · FRInserm · FRNetApp (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ethosuximide, the first-line therapy for childhood absence epilepsy, is currently formulated as a syrup (Zarontin®, Pfizer) with a bitter taste and high sugar content, poorly adapted to children, and a ketogenic diet. The collaborative European FP7 project KIEKIDS aimed at developing an innovative sugar-free, tasteless formulation convenient for pediatric use. This dual Phase-I study evaluated two granule formulations based on lipid multiparticulate (LMP) technology. Two panels of 6 healthy adult volunteers underwent a randomized, placebo-controlled, partly blinded, 3-way cross-over trial, comparing ethosuximide granules A or B with placebo granules and syrup at single 10 mg/kg doses. Corresponding plasma pharmacokinetic profiles of ethosuximide were compared, along with palatability, safety, and tolerability. The LMP granule A proved suboptimal due to bitterness and adherence to beaker walls, while the optimized granule B revealed excellent palatability, similar to placebo granules, and low adherence to glass. The relative bioavailability of granules A versus syrup, based on dose-normalized C

Indexed as

EthosuximideAdultArea Under CurveBiological AvailabilityChildHumansTherapeutic EquivalencyEthosuximidebioequivalenceepilepsypaediatricspharmacokineticsphase I

Identifiers

PMID36537292
PMCPMC9764106
OpenAlexW4312038106

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.