Proposal for a "phase II" multicenter trial model for preclinical new antiepilepsy therapy development

Research output: Contribution to journalArticle

Abstract

There is a pressing need to address the current major gaps in epilepsy treatment, in particular drug-resistant epilepsy, antiepileptogenic therapies, and comorbidities. A major concern in the development of new therapies is that current preclinical testing is not sufficiently predictive for clinical efficacy. Methodologic limitations of current preclinical paradigms may partly account for this discrepancy. Here we propose and discuss a strategy for implementing a "phase II" multicenter preclinical drug trial model based on clinical phase II/III studies designed to generate more rigorous preclinical data for efficacy. The goal is to improve the evidence resulting from preclinical studies for investigational new drugs that have shown strong promise in initial preclinical "phase I" studies. This should reduce the risk for expensive clinical studies in epilepsy and therefore increase the appeal for funders (industry and government) to invest in their clinical development.

Details

Authors
  • Terence J. O'Brien
  • Elinor Ben-Menachem
  • Edward H. III Bertram
  • Stephen D. Collins
  • Merab Kokaia
  • Holger Lerche
  • Henrik Klitgaard
  • Kevin J. Staley
  • Elisabetta Vaudano
  • Matthew C. Walker
  • Michele Simonato
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Neurology

Keywords

  • Preclinical development, Antiepilepsy therapies, Multicenter
Original languageEnglish
Pages (from-to)70-74
JournalEpilepsia
Volume54
Publication statusPublished - 2013
Publication categoryResearch
Peer-reviewedYes

Bibliographic note

The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Restorative Neurology (0131000160)