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Clinical Trials/NCT01563627
NCT01563627CompletedNot Applicable

Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance

University Hospital, Montpellier1 site in 1 country70 target enrollmentStarted: October 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Comparison of Biomarkers

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Antiepileptic Drug resistant

Experimental

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

Intervention: blood sampling for drug resistance biomarkers (Other)

Antiepileptic Drug resistant

Experimental

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

Intervention: Magnetic Resonance Imaging (Device)

Antiepileptic drug Controlled group

Experimental

epilepsy well controlled by antiepileptic drugs

Intervention: blood sampling for drug resistance biomarkers (Other)

Antiepileptic drug Controlled group

Experimental

epilepsy well controlled by antiepileptic drugs

Intervention: Magnetic Resonance Imaging (Device)

Outcomes

Primary Outcomes

Comparison of Biomarkers

Time Frame: 12 months after inclusion (day 0)

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

Secondary Outcomes

  • permeability of the blood-brain barrier(Day 0)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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