Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Monotherapy trials: prerequisite data.

M J Brodie1

  • 1Epilepsy Unit, University Department of Medicine & Therapeutics, Western Infirmary, G11 6NT, Glasgow, UK. martin.j.brodie@clinmed.gla.ac.uk

Epilepsy Research
|July 20, 2001
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Perampanel for focal epilepsy: insights from early clinical experience.

Acta neurologica Scandinavica·2015
Same author

Zonisamide: its pharmacology, efficacy and safety in clinical trials.

Acta neurologica Scandinavica. Supplementum·2012
Same author

Patterns of treatment response in newly diagnosed epilepsy.

Neurology·2012
Same author

Adjunctive pregabalin for uncontrolled partial-onset seizures: findings from a prospective audit.

Acta neurologica Scandinavica·2011
Same author

Biphasic O-deethylation of phenacetin and 7-ethoxycoumarin by human and rat liver microsomal fractions.

Biochemical pharmacology·2010
Same author

Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy.

Neurology·2010

New antiepileptic drugs (AEDs) require monotherapy trials, even if effective as add-on treatments. Efficacy in add-on studies may not translate to monotherapy due to drug interactions, necessitating distinct trials for licensing.

Area of Science:

  • Neurology
  • Pharmacology
  • Clinical Trials

Background:

  • Refractory epilepsy often requires add-on antiepileptic drug (AED) therapy.
  • Efficacy as adjunctive treatment does not always predict monotherapy effectiveness for AEDs.
  • Pharmacokinetic/pharmacodynamic interactions can influence AED efficacy in combination therapy.

Purpose of the Study:

  • To determine if AEDs effective in add-on therapy also demonstrate efficacy as monotherapy.
  • To evaluate the necessity of distinct monotherapy trials for new AED licensing.
  • To establish optimal trial designs for assessing AED monotherapy efficacy.

Main Methods:

  • Review of comparative studies and evidence on AED mechanisms of action.
  • Analysis of pharmacokinetic/pharmacodynamic interactions between AEDs.

Related Experiment Videos

  • Proposal for a phased trial approach including withdrawal and comparative designs.

    • Main Results:

    • Add-on efficacy does not guarantee monotherapy effectiveness for AEDs.
    • Subtle drug interactions can create apparent efficacy in add-on studies.
    • AEDs acting differently from carbamazepine may show varied comparative efficacy.

    Conclusions:

    • Monotherapy trials are essential for licensing new AEDs.
    • Trials should follow initial proof-of-concept studies (e.g., withdrawal) and dose-ranging Phase III trials.
    • Sponsors should be able to seek licenses for both first-line and substitution monotherapy.