ReviewDrugs2008
Antiepileptic drug development in children: considerations for a revisited strategy.
Review in Drugs, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses 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
11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Meta-analysis of drug efficacy in adult vs pediatric trials of patients with PGTC seizures.Neurology · 2020Pooled it
- Efficacy of antiepileptic drugs in adults predicts efficacy in children: a systematic review.Neurology · 2012Pooled it
- Innovative study design for paediatric clinical trials.European journal of clinical pharmacology · 2011Pooled it
- Greater response to placebo in children than in adults: a systematic review and meta-analysis in drug-resistant partial epilepsy.PLoS medicine · 2008Pooled it
- Trial
- Extrapolation of a Brivaracetam Exposure-Response Model from Adults to Children with Focal Seizures.Clinical pharmacokinetics · 2018Trial
- 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
- Investigator-initiated randomized controlled trials in children with epilepsy: Mission impossible?Epilepsia open · 2017Article
- The challenges and innovations for therapy in children with epilepsy.Nature reviews. Neurology · 2014Review
- A revisited strategy for antiepileptic drug development in children: designing an initial exploratory step.CNS drugs · 2013Review
- Comparison of Brain Maturation among Species: An Example in Translational Research Suggesting the Possible Use of Bumetanide in Newborn.Frontiers in neurology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The European Commission and the European Parliament have acknowledged the specific need for a proper evaluation of new drugs in children. The evaluation of the antiepileptic drugs (AEDs) available on the market illustrates the deficit in therapeutic trials for childhood epilepsy syndromes. Currently, the development of AEDs is mainly performed in children with focal epilepsy, whereas infants and the specific age-related epilepsy syndromes, particularly epileptic encephalopathies, are neglected. Infantile epilepsies remain 'therapeutic orphans', although they are the most frequent and deleterious disorders in the area of epilepsy. In order to circumvent the difficulties faced when conducting AED trials in children, we addressed the question of improving feasibility without decreasing quality, while optimally taking into account paediatric ethical requirements. For this review, we first raise the issues of paediatric epilepsies that require special considerations for randomized controlled trials (RCTs) in children. Then, we attempt to determine to what extent adult data could be extrapolated to children. Finally, we review innovative approaches that could be used in the evaluation of AEDs in children. The main specificities of paediatric epilepsies (heterogeneity, severity, cognitive impact, pharmacoresistance, syndrome-specific efficacy profile) are related to brain development and should be taken into consideration when establishing specific guidelines for the evaluation of AEDs in children. Extrapolating efficacy data from adults to children may be possible in focal epilepsy except in infants who need age-specific trials. Epileptic encephalopathies do not exist in adults and require specific trials. Pharmacokinetic data are required below a lower age limit for extrapolation of adult data to be determined in a case-to-case approach. Safety data are required at any paediatric age. RCTs in small but homogeneous populations in each paediatric-specific epileptic syndrome, the use of sequential or responder-enrichment designs, and population pharmacokinetics represent potentially promising approaches to evaluate drugs in children in an efficient way.
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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.