ReviewPaediatric drugs2018
A Review of the New Antiepileptic Drugs for Focal-Onset Seizures in Pediatrics: Role of Extrapolation.
Review in Paediatric drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.
- Comparative antiseizure medications of adjunctive treatment for children with drug-resistant focal-onset seizures: A systematic review and network meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Article
- Article
- Midazolam Oromucosal Solution for the Management of Prolonged Convulsive Seizures in Adult Outpatients: Addressing Unmet Needs in Europe.Clinical drug investigation · 2025Review
- Did pediatric drug development advance epilepsy treatment in young patients? It is time for new research goals.World journal of methodology · 2024Review
- Comparative Outcomes of Levetiracetam and Phenobarbital Usage in the Treatment of Neonatal Seizures: A Retrospective Analysis.Healthcare (Basel, Switzerland) · 2024Article
- Considerations for determining the efficacy of new antiseizure medications in children age 1 month to younger than 2 years.Epilepsia · 2022Article
- Young children with multidrug-resistant epilepsy and vagus nerve stimulation responding to perampanel: A case report.World journal of clinical cases · 2022Article
- Treatment of Focal-Onset Seizures in Children: Should This Be More Etiology-Driven?Frontiers in neurology · 2022Review
- Pregabalin Population Pharmacokinetic and Exposure-Response Analyses for Focal Onset Seizures in Children (4-16 years) and Adults, to Support Dose Recommendations in Children.Clinical pharmacology and therapeutics · 2021Article
- Comparison of the Therapeutic Effects of Sodium Valproate and Levetiracetam on Pediatric Epilepsy and the Effects of Nerve Growth Factor and γ-Aminobutyric Acid.Iranian journal of public health · 2021Article
- Paediatric extrapolation: the panacea for paediatric drug development?British journal of clinical pharmacology · 2019Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Most antiepileptic drugs (AEDs) receive regulatory approval for children years after the drug is available in adults, encouraging off-label use of the drug in children and hindering attempts to obtain quality pediatric data in controlled trials. Extrapolating adult efficacy data to pediatrics can reduce the time between approval in adults and that in children. To extrapolate efficacy from adults to children, several assumptions must be supported, such as (1) a similar disease progression and response to interventions in adults and children, and (2) similar exposure response in adults and children. The Pediatric Epilepsy Academic Consortium for Extrapolation (PEACE) addressed these assumptions in focal-onset seizures (FOS), the most common seizure type in both adults and children. PEACE reviewed the biological and clinical evidence that supported the assumptions that children with FOS have a similar disease progression and response to intervention as adults with FOS. After age 2 years, the pathophysiological underpinnings of FOS and the biological milieu in which seizures are initiated and propagated in children, seizure semiology, electroencephalographic features, etiology and AED response to FOS in children are similar to those in adults with FOS. PEACE concluded that extrapolation of efficacy data in adults to pediatrics in FOS is supported by strong scientific and clinical evidence. However, safety and pharmacokinetic (PK) data cannot be extrapolated from adults to children. Based on extrapolation, eslicarbazepine is now approved for children with FOS, down to age 4 years. Perampanel, lacosamide and brivaracetam are now undergoing PK and safety studies for the purposes of extrapolation down to age 2 or 4 years. When done in conjunction with PK and safety investigations in children, extrapolation of adult data from adults to children can reduce the time delay between approval of effective and safe AEDs in adults and approval in children.
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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.