Literature DB >> 22368524

Trial Design: How Do We Figure Out if an AED Works.

Jacqueline A French1.   

Abstract

Regulatory trials rigorously test the ability of a treatment to impact a known outcome, such as seizure frequency, as measured in well-controlled trials. Such outcomes are called efficacy outcomes. Sometimes these measured outcomes do not reflect the true effectiveness of the drug in the clinic. This article provides some examples of how this can happen and also discusses trials intended to measure effectiveness.

Entities:  

Year:  2012        PMID： 22368524      PMCID： PMC3280467          DOI： 10.5698/1535-7511-12.1.24

Source DB:  PubMed          Journal:  Epilepsy Curr        ISSN： 1535-7511            Impact factor:   7.500


  12 in total

Review 1.  Clinical development of drugs for epilepsy: a review of approaches in the United States and Europe.

Authors:  Roger J Porter; Michel Baulac; Virinder Nohria
Journal:  Epilepsy Res       Date:  2010-03-29       Impact factor: 3.045

2.  Tiagabine: efficacy and safety in adjunctive treatment of partial seizures.

Authors:  P Crawford; H Meinardi; S Brown; T W Rentmeester; B Pedersen; P C Pedersen; L C Lassen
Journal:  Epilepsia       Date:  2001-04       Impact factor: 5.864

Review 3.  Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response.

Authors:  Hans-Georg Eichler; Eric Abadie; Alasdair Breckenridge; Bruno Flamion; Lars L Gustafsson; Hubert Leufkens; Malcolm Rowland; Christian K Schneider; Brigitte Bloechl-Daum
Journal:  Nat Rev Drug Discov       Date:  2011-07-01       Impact factor: 84.694

4.  New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine.

Authors:  A J Rowan; R E Ramsay; J F Collins; F Pryor; K D Boardman; B M Uthman; M Spitz; T Frederick; A Towne; G S Carter; W Marks; J Felicetta; M L Tomyanovich
Journal:  Neurology       Date:  2005-06-14       Impact factor: 9.910

5.  Responsive cortical stimulation for the treatment of medically intractable partial epilepsy.

Authors:  Martha J Morrell
Journal:  Neurology       Date:  2011-09-14       Impact factor: 9.910

6.  Aggravation of partial seizures by antiepileptic drugs: is there evidence from clinical trials?

Authors:  Ernest R Somerville
Journal:  Neurology       Date:  2002-07-09       Impact factor: 9.910

7.  Vagus nerve stimulation for treatment of partial seizures: 3. Long-term follow-up on first 67 patients exiting a controlled study. First International Vagus Nerve Stimulation Study Group.

Authors:  R George; M Salinsky; R Kuzniecky; W Rosenfeld; D Bergen; W B Tarver; J F Wernicke
Journal:  Epilepsia       Date:  1994 May-Jun       Impact factor: 5.864

Review 8.  Epilepsy in later life.

Authors:  Martin J Brodie; Andrew T Elder; Patrick Kwan
Journal:  Lancet Neurol       Date:  2009-10-01       Impact factor: 44.182

9.  The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial.

Authors:  Anthony G Marson; Asya M Al-Kharusi; Muna Alwaidh; Richard Appleton; Gus A Baker; David W Chadwick; Celia Cramp; Oliver C Cockerell; Paul N Cooper; Julie Doughty; Barbara Eaton; Carrol Gamble; Peter J Goulding; Stephen J L Howell; Adrian Hughes; Margaret Jackson; Ann Jacoby; Mark Kellett; Geoffrey R Lawson; John Paul Leach; Paola Nicolaides; Richard Roberts; Phil Shackley; Jing Shen; David F Smith; Philip E M Smith; Catrin Tudur Smith; Alessandra Vanoli; Paula R Williamson
Journal:  Lancet       Date:  2007-03-24       Impact factor: 79.321

10.  The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial.

Authors:  Anthony G Marson; Asya M Al-Kharusi; Muna Alwaidh; Richard Appleton; Gus A Baker; David W Chadwick; Celia Cramp; Oliver C Cockerell; Paul N Cooper; Julie Doughty; Barbara Eaton; Carrol Gamble; Peter J Goulding; Stephen J L Howell; Adrian Hughes; Margaret Jackson; Ann Jacoby; Mark Kellett; Geoffrey R Lawson; John Paul Leach; Paola Nicolaides; Richard Roberts; Phil Shackley; Jing Shen; David F Smith; Philip E M Smith; Catrin Tudur Smith; Alessandra Vanoli; Paula R Williamson
Journal:  Lancet       Date:  2007-03-24       Impact factor: 79.321
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  1 in total

1.  EpiNet as a way of involving more physicians and patients in epilepsy research: Validation study and accreditation process.

Authors:  Peter S Bergin; Ettore Beghi; Lynette G Sadleir; Alice Brockington; Manjari Tripathi; Mark P Richardson; Elisa Bianchi; Kavita Srivastava; Jayaganth Jayabal; Benjamin Legros; Michel Ossemann; Nicole McGrath; Alberto Verrotti; Hui Jan Tan; Simone Beretta; Richard Frith; Ivan Iniesta; Emma Whitham; Jithangi Wanigasinghe; Birinus Ezeala-Adikaibe; Pasquale Striano; Ian Rosemergy; Elizabeth B Walker; Maia Alkhidze; Ildefonso Rodriguez-Leyva; Jose Alfredo Ramírez González; Wendyl J D'Souza
Journal:  Epilepsia Open       Date:  2017-01-03
  1 in total

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