Evidence map›Paper›PMID 33228736›Full record

ArticleTrials2020

Corticosteroids versus clobazam in epileptic encephalopathy with ESES: a European multicentre randomised controlled clinical trial (RESCUE ESES*).

Bart van den Munckhof, Alexis Arzimanoglou, Emilio Perucca, Heleen C van Teeseling, Frans S S Leijten, Kees P J Braun, Floor E Jansen, RESCUE ESES study group

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
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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 3 institutions in 4 countries.

Bart van den MunckhofDepartment of Paediatric Neurology, Brain Center, University Medical Center Utrecht, Member of the European Reference Network EpiCARE, Utrecht University, KC 03.063.0, PO Box 85090, 3508 AB, Utrecht, The Netherlands.
Alexis ArzimanoglouPaediatric Clinical Epileptology, Sleep Disorders and Functional Neurology Department, University Hospitals of Lyon (HCL), Coordinator of the European Reference Network EpiCARE, Lyon Neurosciences Research Centre, Lyon, France.
Emilio PeruccaClinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia and Clinical Trial Center, IRCCS Mondino Foundation, Member of the European Reference Network EpiCARE, Pavia, Italy.
Heleen C van TeeselingDepartment of Paediatric Neuropsychology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Frans S S LeijtenDepartment of Clinical Neurophysiology, Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Kees P J BraunDepartment of Paediatric Neurology, Brain Center, University Medical Center Utrecht, Member of the European Reference Network EpiCARE, Utrecht University, KC 03.063.0, PO Box 85090, 3508 AB, Utrecht, The Netherlands.
Floor E JansenDepartment of Paediatric Neurology, Brain Center, University Medical Center Utrecht, Member of the European Reference Network EpiCARE, Utrecht University, KC 03.063.0, PO Box 85090, 3508 AB, Utrecht, The Netherlands. F.E.Jansen@umcutrecht.nl.
RESCUE ESES study group
Utrecht University · NLUniversity Medical Center Utrecht · NLUniversity of Pavia · IT

Funding

Epilepsiefonds 13-17Wilhelmina Kinderziekenhuis R2634
6 · The paper itself

Abstract

backgroundEpileptic encephalopathy with electrical status epilepticus in sleep (ESES) is an epilepsy syndrome occurring almost exclusively in children, usually at an age between 4 and 12 years. It is characterised by abundant sleep-induced epileptic activity in the electroencephalogram (EEG) and by acquired cognitive and behavioural deficits. The goal of treatment is to prevent further decline or even improve cognitive functioning. Based on mostly small and retrospective studies, corticosteroids and clobazam are regarded by many clinicians as the most effective pharmacological treatments. This European multicentre randomised controlled trial is designed to compare the effects of corticosteroids and clobazam on cognitive functioning after 6 months. Secondary outcomes include cognitive functioning after 18 months, EEG abnormalities in sleep, safety and tolerability, and seizure frequency. We also aimed at investigating whether treatment response in epileptic encephalopathy with ESES can be predicted by measurement of inflammatory mediators and autoantibodies in serum.

methodsThe pragmatic study will be performed in centres with expertise in the treatment of rare paediatric epilepsy syndromes across Europe. A total of 130 patients, 2 to 12 years of age, with epileptic encephalopathy with ESES will be enrolled and randomised in a 1:1 ratio to receive either corticosteroids (monthly intravenous methylprednisolone pulses or daily oral prednisolone) or oral clobazam for 6 months according to an open-label parallel-group design. Follow-up visits with clinical assessment, EEGs, and neuropsychological testing are scheduled for up to 18 months. Blood samples for cytokine and autoantibody testing are obtained before treatment and 8 months after treatment initiation. DISCUSSION: The treatment of epileptic encephalopathy with ESES aims at improving cognitive outcome. This randomised controlled study will compare the most frequently used treatments, i.e. corticosteroids and clobazam. If the study proves superiority of one treatment over the other or identifies biomarkers of treatment response, results will guide clinicians in the early treatment of this severe epilepsy syndrome.

trial registrationISRCTN, ISRCTN42686094 . Registered on 24 May 2013.

Indexed as

EpilepsyStatus EpilepticusAdrenal Cortex HormonesChildChild, PreschoolClobazamElectroencephalographyEuropeHumansInfantMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicRetrospective StudiesSleepAdrenal Cortex HormonesClobazamClobazamCognitionCorticosteroidsCSWSEpilepsyESESNeuropsychologySleep

Identifiers

PMID33228736
PMCPMC7686710
OpenAlexW3109840330

What OpenQuestion holds

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LicenceCC BY
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.