Evidence map›Paper›PMID 39356043›Full record

Trial reportEpilepsia open2024

Treatment with brivaracetam has no apparent long-term effects on body weight in pediatric patients with epilepsy.

Florin I Floricel, Paula E Reichel, Najla Dickson, Sofia Fleyshman, Christoph Reichel, Jan-Peer Elshoff

Registry-linked trialAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Epilepsia open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01364597 (Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy), which is not on this 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.

NCT01364597 phase3completednot on this map

Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

TypeinterventionalSponsorUCB Pharma SARan2011 to 2022Enrolled257ConditionsEpilepsyArmsBrivaracetam (BRV)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
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

6 authors.

Florin I FloricelUCB Pharma, Monheim am Rhein, Germany.ORCID https://orcid.org/0009-0008-4982-1092
Paula E ReichelInstitute of Nutritional Medicine, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.ORCID https://orcid.org/0009-0008-2789-7176
Najla DicksonUCB Pharma, Morrisville, North Carolina, USA.
Sofia FleyshmanUCB Pharma, Morrisville, North Carolina, USA.
Christoph ReichelUCB Pharma, Monheim am Rhein, Germany.ORCID https://orcid.org/0009-0001-8145-2767
Jan-Peer ElshoffUCB Pharma, Monheim am Rhein, Germany.

Funding

UCB Pharma Germany
6 · The paper itself

Abstract

objectiveThe objective of this study is to evaluate possible long-term effects of treatment with brivaracetam (BRV) on body weight in children with epilepsy.

methodPost hoc analysis of data from patients (aged 1 month to <17 years) with ≥6 months of BRV treatment in a long-term, open-label trial (N01266 [NCT01364597]). Outcomes included body weight and body mass index (BMI) over time (z-score growth curves), and treatment-emergent adverse events (TEAEs). Previous/ongoing medical conditions that may affect body weight (gastrointestinal and metabolic/nutritional disorders); concomitant antiseizure medications (ASMs) were also evaluated.

resultsTwo hundred nine patients (mean [standard deviation] age 7.9 [4.6] years) were analyzed. Most (154 [73.7%]) had focal-onset seizures. At study initiation, median (range) BRV dose was 1.0 (0.4-7.5) mg/kg/day. Overall, 189 (90.4%) patients had a previous or ongoing medical condition (gastrointestinal disorders: 43 [20.6%]; metabolism/nutritional disorders: 26 [12.4%]). Most patients followed z-score curves for body weight and BMI during BRV treatment, although there were outliers in both directions. Incidences of appetite/weight-change TEAEs were low. Twenty-three (11.0%) patients had a TEAE of decreased appetite and 14 (6.7%) had a TEAE of weight decreased. SIGNIFICANCE: Long-term adjunctive BRV was well tolerated in growing children with no indication of detrimental effects on body weight. PLAIN LANGUAGE SUMMARY: Brivaracetam is an antiseizure medication (ASM) used to treat seizures in people with epilepsy. Some ASMs can lead to changes in people's appetite and weight. Knowing the effect a drug has on appetite and weight is particularly important in children. We looked at 209 children with epilepsy taking brivaracetam and studied changes in their body weight and body mass index over time. The number of reported side effects related to appetite or weight change was low. There was no apparent long-term effect on their body weight, even when taking their medical history and use of other ASMs into account.

Indexed as

AnticonvulsantsBody WeightEpilepsyPyrrolidinonesAdolescentBody Mass IndexChildChild, PreschoolFemaleHumansInfantMaleAnticonvulsantsbrivaracetamPyrrolidinonesAntiseizure medicationbody weightBrivaracetamepilepsylong‐term study

Identifiers

PMID39356043
PMCPMC11633704

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Registered trials

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.