Trial reportEpilepsia2013
The established status epilepticus trial 2013.
Trial report in Epilepsia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01960075 (A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus.), which is not on this map. Cited by 36 papers, 1 of them a synthesis that pooled 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.
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.
A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus.
Who cites it
36 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of intravenous valproate for status epilepticus: a systematic review.CNS drugs · 2014Pooled it
- Levetiracetam as an alternative to phenytoin for second-line emergency treatment of children with convulsive status epilepticus: the EcLiPSE RCT.Health technology assessment (Winchester, England) · 2020Trial
- Randomized, Multicenter Trial of ARTSS-2 (Argatroban With Recombinant Tissue Plasminogen Activator for Acute Stroke).Stroke · 2017Trial
- Status epilepticus: Updates on mechanisms and treatments.Epilepsia open · 2025Review
- Strategies to innovate emergency care of status epilepticus.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Review
- Refractory and Super-refractory Status Epilepticus.Indian pediatrics · 2020Review
- Big data in status epilepticus.Epilepsy & behavior : E&B · 2019Review
- Lessons from the Established Status Epilepticus Treatment Trial.Epilepsy & behavior : E&B · 2019Review
- Levetiracetam versus phenytoin in children with status epilepticus.Journal of family medicine and primary care · 2019Article
- Underdosing of Benzodiazepines in Patients With Status Epilepticus Enrolled in Established Status Epilepticus Treatment Trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2019Article
- Antiseizure medications in critical care: an update.Current opinion in critical care · 2019Review
- In Situ Simulation to Mitigate Threats to Participation in a Multicenter Clinical Trial in High-Acuity, Low-Frequency Setting.Simulation in healthcare : journal of the Society for Simulation in Healthcare · 2019Article
- The 'top 100' drugs and classes in England: an updated 'starter formulary' for trainee prescribers.British journal of clinical pharmacology · 2018Article
- Seizures and epilepsy in the acute medical setting: presentation and management.Clinical medicine (London, England) · 2018Article
- Association of Time to Treatment With Short-term Outcomes for Pediatric Patients With Refractory Convulsive Status Epilepticus.JAMA neurology · 2018Observational
- Review
- Review
- Electroencephalography and behavior patterns during experimental status epilepticus.Epilepsia · 2018Article
- Flupirtine and diazepam combination terminates established status epilepticus: results in three rodent models.Annals of clinical and translational neurology · 2017Article
- Recent advances in epilepsy.Journal of neurology · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
Benzodiazepine-refractory status epilepticus (established status epilepticus, ESE) is a relatively common emergency condition with several widely used treatments. There are no controlled, randomized, blinded clinical trials to compare the efficacy and tolerability of currently available treatments for ESE. The ESE treatment trial is designed to determine the most effective and/or the least effective treatment of ESE among patients older than 2 years by comparing three arms: fosphenytoin (fPHT) levetiracetam (LVT), and valproic acid (VPA). This is a multicenter, randomized, double-blind, Bayesian adaptive, phase III comparative effectiveness trial. Up to 795 patients will be randomized initially 1:1:1, and response-adaptive randomization will occur after 300 patients have been recruited. Randomization will be stratified by three age groups, 2-18, 19-65, and 66 and older. The primary outcome measure is cessation of clinical seizure activity and improving mental status, without serious adverse effects or further intervention at 60 min after administration of study drug. Each subject will be followed until discharge or 30 days from enrollment. This trial will include interim analyses for early success and futility. This trial will be considered a success if the probability that a treatment is the most effective is >0.975 or the probability that a treatment is the least effective is >0.975 for any treatment. Proposed total sample size is 795, which provides 90% power to identify the most effective and/or the least effective treatment when one treatment arm has a true response rate of 65% and the true response rate is 50% in the other two arms.
Indexed as
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What OpenQuestion holds
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.