Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01563627
First received: March 9, 2012
Last updated: April 10, 2014
Last verified: April 2014

March 9, 2012
April 10, 2014
October 2011
October 2015   (final data collection date for primary outcome measure)
Comparison of Biomarkers [ Time Frame: 12 months after inclusion (day 0) ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01563627 on ClinicalTrials.gov Archive Site
permeability of the blood-brain barrier [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups
Same as current
Not Provided
Not Provided
 
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Epilepsy
Other: blood sampling for drug resistance biomarkers
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
  • Experimental: Antiepileptic Drug resistant
    Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates
    Intervention: Other: blood sampling for drug resistance biomarkers
  • Experimental: Antiepileptic drug Controlled group
    epilepsy well controlled by antiepileptic drugs
    Intervention: Other: blood sampling for drug resistance biomarkers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2016
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Arielle CRESPEL, MD 04 67 33 72 40 a-crespel@chu-montpellier.fr
France
 
NCT01563627
8668
Yes
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Not Provided
University Hospital, Montpellier
April 2014

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