Completed

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

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What is being tested

retigabine

+ placebo

Drug
Who is being recruted

Brain Diseases+1

+ Central Nervous System Diseases

+ Nervous System Diseases

From 18 to 50 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity Hospital of Mont-Godinne
Last updated: December 2, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01823159
Principal SponsorUniversity Hospital of Mont-Godinne
Last updated: December 2, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsy

Criteria

3 inclusion criteria required to participate
age 18-50 years

being "healthy"

willing to participate and able to understand study and provide informed consent

5 exclusion criteria prevent from participating
alcohol or drug abuse

antecedent of seizure

contra-indication to TMS (metal in the head, skull fracture)

contra-indication to retigabine

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Administration of a single dose of 400 mg retigabine, two hours before the measures

Group II

Placebo
Randomized administration of a single dose of placebo, two hours before the measures.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CHU Mont-Godinne

Yvoir, BelgiumOpen CHU Mont-Godinne in Google Maps
CompletedOne Study Center