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 Concept Videos

Epilepsy and Seizures: Overview01:24

Epilepsy and Seizures: Overview

Epilepsy is a chronic neurological disease marked by recurrent, unpredictable seizures. These seizures are caused by abnormal electrical discharges in the brain, leading to behavior, sensation, or consciousness alterations. They can also cause transient impairment of awareness, interfering with daily activities.
Various factors can trigger epilepsy, including genetic factors, brain damage, metabolic causes, and unknown etiology. Diagnosis of epilepsy involves electroencephalography (EEG), which...
Antiepileptic Drugs: Modulators of Neurotransmitter Release Mediated by SV2A Protein01:20

Antiepileptic Drugs: Modulators of Neurotransmitter Release Mediated by SV2A Protein

Antiepileptic drugs, such as levetiracetam (Keppra) and brivaracetam (Briviact), have emerged as crucial tools in managing epilepsy. These medications exert their therapeutic effects by targeting the synaptic vesicle protein SV2A, a transmembrane glycoprotein primarily found in the brain.
SV2A is a transmembrane glycoprotein located predominantly in the brain, modulating the release of neurotransmitters for neuronal communication. Both levetiracetam and brivaracetam exhibit a high affinity for...
Antiepileptic Drugs: GABAergic Pathway Potentiators01:18

Antiepileptic Drugs: GABAergic Pathway Potentiators

γ-aminobutyric acid or GABA, plays a pivotal role as an inhibitory neurotransmitter in the brain. GABA pathway potentiators, also known as GABAergic drugs, are a class of pharmaceutical agents designed to enhance the functioning of the GABAergic system. These medications primarily treat epilepsy, a neurological disorder characterized by recurrent seizures.
The key GABA pathway potentiators used in epilepsy management are as follows.
Benzodiazepines are a well-known class of drugs used for their...
Antiepileptic Drugs: Potassium Channel Activators01:20

Antiepileptic Drugs: Potassium Channel Activators

Ezocgabine or retigabine, an antiepileptic drug of remarkable efficacy, has revolutionized the management of seizures. It is a potassium channel activator, explicitly targeting the family of Q subtype potassium channels. It enhances the transmembrane potassium currents, regulating neuronal excitability. This action stabilizes the resting membrane potential, a pivotal factor in mitigating the hyperexcitability that characterizes epilepsy.
Ezogabine has gained approval as an adjunctive treatment...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Antiepileptic Drugs: Glutamate Antagonists01:14

Antiepileptic Drugs: Glutamate Antagonists

Glutamate is a fundamental neurotransmitter in the central nervous system, playing a vital role in neuronal communication and various cognitive processes. Glutamate stands as the principal excitatory neurotransmitter in the brain. Its presence is crucial for the communication between neurons, underpinning essential processes such as synaptic transmission, neuronal excitability, and plasticity. These functions are vital for higher-order cognitive processes, including learning and memory. The...

You might also read

Related Articles

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

Sort by
Same author

Accelerated long-term forgetting in people with newly diagnosed focal epilepsy.

Epilepsy & behavior : E&B·2026
Same author

e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence.

Trials·2023
Same author

Using routinely recorded data in a UK RCT: a comparison to standard prospective data collection methods.

Trials·2021
Same author

Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.

The British journal of surgery·2021
Same author

Thalamohippocampal atrophy in focal epilepsy of unknown cause at the time of diagnosis.

European journal of neurology·2020
Same author

A core outcome set for pre-eclampsia research: an international consensus development study.

BJOG : an international journal of obstetrics and gynaecology·2020

Related Experiment Video

Updated: Jun 22, 2026

Microdialysis of Excitatory Amino Acids During EEG Recordings in Freely Moving Rats
08:47

Microdialysis of Excitatory Amino Acids During EEG Recordings in Freely Moving Rats

Published on: November 8, 2018

Interpreting regulatory trials in epilepsy.

A G Marson1, P R Williamson

  • 1The University of Liverpool, Liverpool, UK. a.g.marson@liv.ac.uk

Current Opinion in Neurology
|June 18, 2009
PubMed
Summary

Regulatory trials for antiepileptic drugs have limitations. Monotherapy trial designs differ between agencies, potentially exposing patients to unacceptable risks and complicating clinical decisions.

More Related Videos

Network Analysis of Foramen Ovale Electrode Recordings in Drug-resistant Temporal Lobe Epilepsy Patients
09:32

Network Analysis of Foramen Ovale Electrode Recordings in Drug-resistant Temporal Lobe Epilepsy Patients

Published on: December 18, 2016

Related Experiment Videos

Last Updated: Jun 22, 2026

Microdialysis of Excitatory Amino Acids During EEG Recordings in Freely Moving Rats
08:47

Microdialysis of Excitatory Amino Acids During EEG Recordings in Freely Moving Rats

Published on: November 8, 2018

Network Analysis of Foramen Ovale Electrode Recordings in Drug-resistant Temporal Lobe Epilepsy Patients
09:32

Network Analysis of Foramen Ovale Electrode Recordings in Drug-resistant Temporal Lobe Epilepsy Patients

Published on: December 18, 2016

Area of Science:

  • Neurology
  • Clinical Pharmacology
  • Regulatory Science

Background:

  • An increasing number of antiepileptic drugs (AEDs) are licensed, primarily for add-on therapy.
  • Regulatory trials are the primary evidence base for clinical decisions regarding AED use.
  • Trial designs for AED monotherapy are particularly controversial due to differing regulatory interpretations.

Purpose of the Study:

  • To review the interpretation of regulatory randomized controlled trials for AEDs.
  • To highlight controversies in monotherapy trial designs and their implications.
  • To discuss the impact of trial design on patient risk and clinical decision-making.

Main Methods:

  • Review of regulatory trial designs for antiepileptic drugs.
  • Analysis of differing interpretations by regulatory bodies (e.g., EMA, FDA).
  • Examination of trial designs for add-on therapy versus monotherapy.

Main Results:

  • Placebo-controlled add-on trials clearly demonstrate efficacy versus placebo but do not aid drug selection.
  • The European Medicines Agency accepts noninferiority head-to-head trials for monotherapy licensing.
  • The US Food and Drug Administration requires superiority trials, leading to 'pseudoplacebo' designs that pose risks to patients.

Conclusions:

  • Current regulatory trials for AEDs possess significant limitations for informing clinical practice.
  • Discrepancies in monotherapy trial requirements necessitate addressing these limitations.
  • Patient safety and informed clinical decision-making require improved regulatory trial designs.