NCT01823159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

March 24, 2013

Last Update Submit

December 1, 2014

Conditions

Epilepsy

Keywords

retigabinecortical excitabilityTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Measurement of TMS cortical excitability parameter before and after drug 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.

    Two hours after oral intake

Secondary Outcomes (1)

  • Assessing tolerability of a single dose intake of retigabine

    24 hours after drug intake

Study Arms (2)

Retigabine

ACTIVE COMPARATOR

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

Drug: retigabine

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

retigabineDRUG

Single oral administration of a 400 mg tablet.

Also known as: ezogabine
Retigabine
placeboDRUG

Single oral administration of a tablet

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-50 years
  • being "healthy"
  • willing to participate and able to understand study and provide informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Mont-Godinne

Yvoir, Namur, 5350, Belgium

Location

MeSH Terms

Conditions

Epilepsy

Interventions

ezogabine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michel Ossemann, MD

    CHU Mont-Godinne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2013

First Posted

April 4, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

BE(1)