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

• ClinicalTrials.gov Identifier: NCT01563627
• Recruitment Status: Completed
• First Posted: March 27, 2012
• Last Update Posted: June 1, 2016
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Tracking Information

• First Submitted Date: March 9, 2012
• First Posted Date: March 27, 2012
• Last Update Posted Date: June 1, 2016
• Study Start Date: October 2011
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2012)

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01563627 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: March 26, 2012)

permeability of the blood-brain barrier [ Time Frame: Day 0 ]

Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Epilepsy

Intervention

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

Study Arms

• Experimental: Antiepileptic Drug resistant
  Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates
  Interventions:

  • Other: blood sampling for drug resistance biomarkers
  • Device: Magnetic Resonance Imaging
• Experimental: Antiepileptic drug Controlled group
  epilepsy well controlled by antiepileptic drugs
  Interventions:

  • Other: blood sampling for drug resistance biomarkers
  • Device: Magnetic Resonance Imaging

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 31, 2016): 70
• Original Estimated Enrollment (submitted: March 26, 2012): 60
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01563627
• Other Study ID Numbers: 8668
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Montpellier
• Study Sponsor: University Hospital, Montpellier
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Montpellier
• Verification Date: May 2016