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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563627
• Other study ID #: 8668
• Status: Completed
• Phase: N/A
• First received: March 9, 2012
• Last updated: May 31, 2016
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

Other:
• blood sampling for drug resistance biomarkers
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy

Device:
• Magnetic Resonance Imaging

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	permeability of the blood-brain barrier	Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups	Day 0	No