Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01823159
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : December 2, 2014
Sponsor:
Collaborators:
GlaxoSmithKline
Université Catholique de Louvain
Information provided by (Responsible Party):
Michel Ossemann, University Hospital of Mont-Godinne

Tracking Information
First Submitted Date  ICMJE March 24, 2013
First Posted Date  ICMJE April 4, 2013
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01823159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study
Official Title  ICMJE Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: retigabine
    Single oral administration of a 400 mg tablet.
    Other Name: ezogabine
  • Drug: placebo
    Single oral administration of a tablet
Study Arms  ICMJE
  • Active Comparator: Retigabine
    Administration of a single dose of 400 mg retigabine, two hours before the measures
    Intervention: Drug: retigabine
  • Placebo Comparator: placebo
    Randomized administration of a single dose of placebo, two hours before the measures.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823159
Other Study ID Numbers  ICMJE CERETI
2012-003809-98 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michel Ossemann, University Hospital of Mont-Godinne
Study Sponsor  ICMJE University Hospital of Mont-Godinne
Collaborators  ICMJE
  • GlaxoSmithKline
  • Université Catholique de Louvain
Investigators  ICMJE
Principal Investigator: Michel Ossemann, MD CHU Mont-Godinne
PRS Account University Hospital of Mont-Godinne
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP