Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults?

NCT02424123 | Terminated

• 2 other identifiers: LOCAL/2014/ET-022015-A00157-42
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

Seizures represent an important clinical problem, accounting for at least 40% of adult onset epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is difficult due to the lack of prognostic biomarkers. Recent evidence has indicated that blood-brain barrier (BBB) dysfunction constitutes an etiological factor to seizures. In particular, it has been shown that modification of BBB permeability is associated with seizure activity. In addition, it was demonstrated that BBB permeability can be assessed by measuring serum level of the protein S100B. Based on these data and considerations the investigators will test whether the extent of BBB damage at time of first seizure is predictive for seizure recurrence. The main objective of this study is to evaluate the association between the absolute (ng/ml) serum S100B levels (measured at time of the first seizure) and the experience, or not, of seizure recurrence within one year of follow-up.

Conditions

Seizures, Epileptic; Epilepsy

Outcome Measures

Primary Outcomes (3)

• Serum S100B level

  ng/ml

  Day 0 (T0+6 hours)

• Serum S100B level

  ng/ml

  Day 0 (T0+12 hours)

• Seizure recurrence within 1 year

  yes/no

  12 months

Secondary Outcomes (15)

• Serum S100B level

  Between days 14 and 28

• Serum S100B level

  6 months

• Serum S100B level

  12 months

• Serum S100B level

  at time of 2nd seizure (expected max of 12 months)

• Serum IL-1b level

  Day 0 (T0+6 hours)

Study Arms (1)

The study population

The study population is composed of patients between 18 and 60 years of age, of both sexes, recruited during consultations for a first epileptic seizure at the emergency department of Nîmes and Marseille Hospitals (CHRU).

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of patients between 18 and 60 years of age, of both sexes, recruited during consultations for a first epileptic seizure at the emergency department of Nîmes and Marseille Hospitals (CHRU).

You may qualify if:

• The patient has been correctly informed.
• The patient must have given his informed and signed consent.
• The patient must be insured or beneficiary of a health insurance plan.
• The patient is at least (≥) 18 years old and less than (\<) 60 years old.
• The patient has experienced a first generalized, epileptic seizure (patients with partial onset and secondary generalization can also be included).
• The seizure has occurred less than 24 hours ago.

You may not qualify if:

• The patient is participating in another study that may interfere with the results or conclusions of this study.
• Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study.
• The patient is under judicial protection.
• The patient refuses to sign the consent.
• It is impossible to correctly inform the patient.
• The patient is pregnant or breast-feeding (MRI contraindicated).
• Patient has a previous abnormal brain imaging (MRI).
• Patient has abnormal biological tests for toxicology (alcohol, cocaine and cannabis tests), blood ionogram (hyponatremia \<130mM), liver enzymes (\>5N), inflammatory syndrome (elevated C-reactive protein).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

APHM - Hôpital Nord

Marseille, 13915, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Processing of blood samples: 4-5ml of the blood sample will be centrifuged to isolate serum; S100B, IL-1b, IL-6, NSE levels will be investigated at D0 (T0+6h, T0+12h where T0 is seizure time) D14-D28. The remaining blood and cells will be stored at -80°C for future analyses.

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicola Marchi, MD

  Institut de Génomique Fonctionnelle, CNRS, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 22, 2015
• Study Start: October 11, 2016
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (2)