Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study (CERETI)
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|ClinicalTrials.gov Identifier: NCT01823159|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: retigabine Drug: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Active Comparator: Retigabine
Administration of a single dose of 400 mg retigabine, two hours before the measures
Single oral administration of a 400 mg tablet.
Other Name: ezogabine
Placebo Comparator: placebo
Randomized administration of a single dose of placebo, two hours before the measures.
Single oral administration of a tablet
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823159
|Yvoir, Namur, Belgium, 5350|
|Principal Investigator:||Michel Ossemann, MD||CHU Mont-Godinne|