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

U

University Hospital of Mont-Godinne

Status and phase

Completed
Phase 3

Conditions

Epilepsy

Treatments

Drug: placebo
Drug: retigabine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01823159
CERETI
2012-003809-98 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups, including a placebo group

Retigabine
Active Comparator group
Description:
Administration of a single dose of 400 mg retigabine, two hours before the measures
Treatment:
Drug: retigabine
placebo
Placebo Comparator group
Description:
Randomized administration of a single dose of placebo, two hours before the measures.
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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