Evidence map›Paper›PMID 36529709›Full record

Trial reportEpilepsia open2023

Safety and tolerability of short-term infusions of intravenous lacosamide in pediatric patients with epilepsy: An open-label, phase 2/3 trial.

Mark Kristof Farkas, Cynthia Beller, Ali Bozorg, Carrie McClung, Robert Roebling, Tanisia Yates, Nancy Yuen, Iryna Makedonska

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Epilepsia open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02710890 (A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide in Children), 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
1.0field-weighted citation impact, top 24% 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.

NCT02710890 phase2 / phase3completednot on this map

A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide in Children (>= 1 Month to < 17 Years of Age) With Epilepsy

TypeinterventionalSponsorUCB BIOSCIENCES, Inc.Ran2017 to 2019Enrolled103ConditionsEpilepsyArmsLacosamide
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 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

8 authors at 4 institutions in 4 countries.

Mark Kristof FarkasFirst Department of Pediatrics, Semmelweis University, Budapest, Hungary.ORCID 0000-0002-6016-2883
Cynthia BellerUCB Pharma, Morrisville, North Carolina, USA.
Ali BozorgUCB Pharma, Morrisville, North Carolina, USA.
Carrie McClungUCB Pharma, Morrisville, North Carolina, USA.
Robert RoeblingUCB Pharma, Monheim am Rhein, Germany.
Tanisia YatesUCB Pharma, Morrisville, North Carolina, USA.
Nancy YuenUCB Pharma, Morrisville, North Carolina, USA.
Iryna MakedonskaDnipro City Pediatric Clinical Hospital, Dnipro, Ukraine.
UCB Pharma (United States) · USRegional Clinical Hospital named after II Mechnikov · UASemmelweis University · HUUCB Pharma (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study is to evaluate the safety and tolerability of intravenous (IV) lacosamide infusion in patients aged ≥1 month to <17 years with epilepsy.

methodsThis Phase 2/3 open-label trial (EP0060; NCT02710890) enrolled patients in two age cohorts (cohort 1: ≥8 to <17 years; cohort 2: ≥1 month to <8 years). Eligible patients were receiving oral lacosamide as adjunctive treatment or monotherapy (in an open-label long-term trial or by prescription) or were not receiving lacosamide before enrolment. Patients initiated IV lacosamide (2-12 mg/kg/day or 100-600 mg/day; 15-60 minutes infusion) as a replacement for oral lacosamide or as adjunctive treatment. The primary outcomes were treatment-emergent adverse events (TEAEs) and discontinuations due to TEAEs.

resultsIn total, 103 patients were enrolled and completed the trial; 55 patients were included in cohort 1 (≥8 to <17 years), 48 in cohort 2 (≥1 month to <8 years). During the 4 weeks before screening, 74 (71.8%) patients had focal seizures, 12 (11.7%) had generalized seizures, and two (1.9%) had unclassified seizures. Most patients (74 [71.8%]) initiated lacosamide as adjunctive IV treatment. The mean overall duration of exposure to IV lacosamide was 1.18 days. Seventy-nine (76.7%) patients had one IV lacosamide infusion, 20 (19.4%) had two, one (1.0%) had three, and three (2.9%) had 10 infusions. Overall, five (4.9%) patients had a total of seven TEAEs. The only TEAEs reported in two or more patients were increased blood triglycerides (two [1.9%]). No serious or severe TEAEs were reported, and no patients discontinued due to TEAEs. No TEAEs were considered drug-related by the investigator. No consistent or clinically relevant treatment-related changes from baseline were observed for hematology, clinical chemistry parameters, vital signs, or 12-lead electrocardiograms. SIGNIFICANCE: IV lacosamide was generally well tolerated in pediatric patients (≥1 month to <17 years) with epilepsy, and no new safety concerns were identified.

Indexed as

AnticonvulsantsEpilepsyAcetamidesChildHumansLacosamideSeizuresAcetamidesAnticonvulsantsLacosamideantiseizure medicationfocal seizureintravenous lacosamidepediatricprimary generalized tonic-clonic seizures

Identifiers

PMID36529709
PMCPMC9977742
OpenAlexW4311870039

What OpenQuestion holds

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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.