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
  Purpose

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.


Condition Intervention
Epilepsy
Other: blood sampling for drug resistance biomarkers

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antiepileptic Drug resistant
Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates
Other: blood sampling for drug resistance biomarkers
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
Experimental: Antiepileptic drug Controlled group
epilepsy well controlled by antiepileptic drugs
Other: blood sampling for drug resistance biomarkers
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563627

Contacts
Contact: Arielle CRESPEL, MD 04 67 33 72 40 a-crespel@chu-montpellier.fr

Locations
France
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Arielle CRESPEL, MD    04 67 33 72 40    a-crespel@chu-montpellier.fr   
Principal Investigator: Arielle CRESPEL, MD         
Sub-Investigator: Philippe GELISSE, MD         
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01563627     History of Changes
Other Study ID Numbers: 8668
Study First Received: March 9, 2012
Last Updated: April 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Anticonvulsants
Immunologic Factors
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014