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Completed

NCT Number: NCT01823159

Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study

The objective of this study is to characterize the effects of a single-dose of retigabine on cortical excitability in healthy subjects, as quantified by means of TMS.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Mont-Godinne

Yvoir, Namur, 5350, Belgium

About this study

Epilepsy is a disorder of brain excitability. Antiepileptic drugs (AEDs) modulate this excitability and transcranial magnetic stimulation (TMS) imposed itself as one of the best noninvasive methods to study cortical excitability in human subjects.

Based on several recent studies, we hypothesize that measuring TMS parameters in the patients suffering from epilepsy can rapidly predict the effectiveness of the newly given AED and, ultimately, guide the optimization of the AED therapy. Characterizing the neurophysiological properties of innovative AEDs such as retigabine with TMS will allow 1) to better understand how AEDs modulate, in vivo, cortical excitability in humans in relation to their mode of action and 2) to establish TMS as a tool for assessing individual responsiveness to a particular AED treatment and for antiepileptic treatment monitoring.

The effects of most AEDs on cortical excitability have been investigated. The modifications of the excitability parameters are related to the specific mode of action of each AED. For the new AED retigabine, at least two modes of action are known: 1) increase in cellular potassium efflux by changing conformation of the KV7.2-7.3 channels and 2) enhancement of GABA-A activity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-50 years
  • being "healthy"
  • willing to participate and able to understand study and provide informed consent

Exclusion criteria

  • intake of psycho-active drugs (AEDS, antidepressants, benzodiazepines, neuroleptics, hypnotics, ...)
  • alcohol or drug abuse
  • antecedent of seizure
  • contra-indication to TMS (metal in the head, skull fracture)
  • contra-indication to retigabine.

Treatment and study plan

Retigabine

Drug

Single oral administration of a 400 mg tablet.

Other names: ezogabine

Placebo

Drug

Single oral administration of a tablet

Primary outcomes

  1. Measurement of TMS cortical excitability parameter before and after drug intake

    Time frame: Two hours after oral intake

    The primary endpoint is the impact of retigabine on TMS cortical excitability parameters in healthy volunteers compared to placebo, in a double-blind cross-over design. These parameters were specifically chosen according to the known dual mechanism of action of retigabine. Modulation of GABA-A receptors and increase of potassium efflux.

    The parameters studied are the motor threshold (MT), the amplitude of motor evoked potential (MEP), the cortical silent period (CSP), the short interval intracortical inhibition (SICI), the long interval intracortical inhibition (LICI), the intracortical facilitation (ICF) and the short interval cortical facilitation (SICF).

    Parameters are registered before and after retigabine or placebo intake. Modifications of these parameters are recorded and compared for retigabine vs placebo for each subject. A group analysis retigabine vs placebo is also performed.

Secondary outcomes

  1. Assessing tolerability of a single dose intake of retigabine

    Time frame: 24 hours after drug intake

    Reporting of eventual side effect after the intake of retigabine vs placebo with a structurate questionnaire.

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Collaborators

  • GlaxoSmithKline
  • Université Catholique de Louvain

Registry information

Acronym: CERETI

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Apr 4, 2013
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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