Journal article
What clinical trial designs have been used to test antiepileptic drugs and do we need to change them?
E Perucca
Epileptic Disorders | JOHN LIBBEY EUROTEXT LTD | Published : 2012
Abstract
Designs used to evaluate the efficacy and safety of antiepileptic drugs (AEDs) have evolved considerably over the years. A major impulse to develop methodologically sound randomised controlled trials dates back to the Kefauver-Harris Drug Amendment of 1962, through which the US congress introduced the requirement of substantial evidence for proof of efficacy in a new drug application. The mainstay for the initial approval of most new AEDs has been, and still is, the placebo-controlled adjunctive therapy trial, which evolved over the years from the cross-over to the parallel-group design. In the early days, when few AEDs were available, enrolment of patients into these trials was relatively e..
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Funding Acknowledgements
[ "Updated following presentation and discussion at the 2011 Progress in Epileptic Disorders Workshop on \"Antiepileptic Drug Trials: will the future challenge the past\" held at the Chaeauform' La Maison des Contes, Dareize, 69490, France. The workshop was partly supported by an educational grant from UCB. The program was under the exclusive responsibility of a Scientific Committee composed by Prs. Philippe Ryvlin (France), Emilio Perucca (Italy), Jackie French (USA), Steve White (USA), Graeme Sills (UK) and Alexis Arzimanoglou (France).", "This work was not supported by any funding source. The author received research grants from the European Union, the Italian Medicines Agency, the Italian Ministry of Health, and the Italian Ministry for Education, University and Research. The author also received speaker's or consultancy fees and/or research grants from Bial, Eisai, GSK, Johnson and Johnson, Novartis, Pfizer, Sepracor, SK Life Sciences Holdings, Supernus, UCB Pharma, Upsher-Smith, Valeant, and Vertex." ]