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Clinical Drug Development in Epilepsy Revisited: A Proposal for a New Paradigm Streamlined Using Extrapolation

Wadsworth, I; Jaki, T; Sills, GJ; Appleton, R; Cross, JH; Marson, AG; Martland, T; ... Hampson, LV; + view all (2016) Clinical Drug Development in Epilepsy Revisited: A Proposal for a New Paradigm Streamlined Using Extrapolation. CNS DRUGS , 30 (11) pp. 1011-1017. 10.1007/s40263-016-0383-y. Green open access

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Abstract

Data from clinical trials in adults, extrapolated to predict benefits in paediatric patients, could result in fewer or smaller trials being required to obtain a new drug licence for paediatrics. This article outlines the place of such extrapolation in the development of drugs for use in paediatric epilepsies. Based on consensus expert opinion, a proposal is presented for a new paradigm for the clinical development of drugs for focal epilepsies. Phase I data should continue to be collected in adults, and phase II and III trials should simultaneously recruit adults and paediatric patients aged above 2 years. Drugs would be provisionally licensed for children subject to phase IV collection of neurodevelopmental safety data in this age group. A single programme of trials would suffice to license the drug for use as either adjunctive therapy or monotherapy. Patients, clinicians and sponsors would all benefit from this new structure through cost reduction and earlier access to novel treatments. Further work is needed to elicit the views of patients, their parents and guardians as appropriate, regulatory authorities and bodies such as the National Institute for Health and Care Excellence (UK). Dr. John M. Pellock sadly passed away after this article was written. The authors would like to acknowledge the important contribution Dr. Pellock made to this article and the field of epilepsy research.

Type: Article
Title: Clinical Drug Development in Epilepsy Revisited: A Proposal for a New Paradigm Streamlined Using Extrapolation
Open access status: An open access version is available from UCL Discovery
DOI: 10.1007/s40263-016-0383-y
Publisher version: http://dx.doi.org/10.1007/s40263-016-0383-y
Additional information: © The Author(s) 2016
Keywords: Science & Technology, Life Sciences & Biomedicine, Clinical Neurology, Pharmacology & Pharmacy, Psychiatry, Neurosciences & Neurology, RANDOMIZED CONTROLLED-TRIAL, ANTIEPILEPTIC DRUGS, CHILDREN, LAMOTRIGINE, EFFICACY, OXCARBAZEPINE, CARBAMAZEPINE, VIGABATRIN, TOPIRAMATE, ADULTS
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Developmental Neurosciences Dept
URI: https://discovery.ucl.ac.uk/id/eprint/1516772
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