NCT01563627

Brief Summary

Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome. Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB. The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

March 9, 2012

Last Update Submit

May 31, 2016

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Comparison of Biomarkers

    Identify blood sampling biomarkers of drug resistance in temporal lobe epilepsy, an analysis by large-scale expression profiling of serum factors involved in inflammation, immunity and angiogenesis

    12 months after inclusion (day 0)

Secondary Outcomes (1)

  • permeability of the blood-brain barrier

    Day 0

Study Arms (2)

Antiepileptic Drug resistant

EXPERIMENTAL

Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates

Other: blood sampling for drug resistance biomarkersDevice: Magnetic Resonance Imaging

Antiepileptic drug Controlled group

EXPERIMENTAL

epilepsy well controlled by antiepileptic drugs

Other: blood sampling for drug resistance biomarkersDevice: Magnetic Resonance Imaging

Interventions

blood sampling for drug resistance biomarkersOTHER

comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy

Antiepileptic Drug resistantAntiepileptic drug Controlled group
Magnetic Resonance ImagingDEVICE
Antiepileptic Drug resistantAntiepileptic drug Controlled group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with temporal lobe epilepsy (TLE)
  • Patient with epilepsy for at least two years. Arm 1: Patient with drug-resistant TLE proved potentially a candidate for surgery.
  • Arm 2: Patient with TLE seizure-free for 12 months or more

You may not qualify if:

  • Patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. ...
  • Patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Blood Specimen CollectionMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesTomographyDiagnostic Imaging

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 27, 2012

Study Start

October 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

FR(1)