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Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sampling for drug resistance biomarkers
Magnetic Resonance Imaging
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Antiepileptic Drug resistant

Antiepileptic drug Controlled group

Arm Description

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

epilepsy well controlled by antiepileptic drugs

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

permeability of the blood-brain barrier
Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups

Full Information

First Posted
March 9, 2012
Last Updated
May 31, 2016
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01563627
Brief Title
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
Official Title
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antiepileptic Drug resistant
Arm Type
Experimental
Arm Description
Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates
Arm Title
Antiepileptic drug Controlled group
Arm Type
Experimental
Arm Description
epilepsy well controlled by antiepileptic drugs
Intervention Type
Other
Intervention Name(s)
blood sampling for drug resistance biomarkers
Intervention Description
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
Comparison of Biomarkers
Description
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
Time Frame
12 months after inclusion (day 0)
Secondary Outcome Measure Information:
Title
permeability of the blood-brain barrier
Description
Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy

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