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

NCT ID: NCT01823159

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Retigabine

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

Group Type ACTIVE_COMPARATOR

retigabine

Intervention Type DRUG

Single oral administration of a 400 mg tablet.

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single oral administration of a tablet

Interventions

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retigabine

Single oral administration of a 400 mg tablet.

Intervention Type DRUG

placebo

Single oral administration of a tablet

Intervention Type DRUG

Other Intervention Names

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ezogabine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role collaborator

University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Michel Ossemann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michel Ossemann, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Mont-Godinne

Locations

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CHU Mont-Godinne

Yvoir, Namur, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2012-003809-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CERETI

Identifier Type: -

Identifier Source: org_study_id