Clinical Trials Directory

Trials / Terminated

TerminatedNCT02424123

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

Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults? A Prognostic Cohort Study

Status
Terminated
Phase
Study type
Observational
Enrollment
37 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
18 Years – 59 Years
Healthy volunteers
Not accepted

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.

Detailed description

The secondary objectives of this study are to investigate the: A) Prognostic capacity of serum S100B levels to predict seizure recurrence. B) Association between the variation (%) of serum S100B levels between first seizure episode and scheduled follow-up (D14-D28) and seizure recurrence. C) Correlation of S100B with IL-1b, IL-6, NSE serum levels at the same time points. D) Association of serology data with: a) EEG profile (normal/abnormal); b) recurrence of seizures (Y/N). E) Comparison of S100B serum levels in lesional vs non-lesional patients. F) Establishment of a bio-bank (serum and cells).

Conditions

Timeline

Start date
2016-10-11
Primary completion
2020-07-30
Completion
2020-07-30
First posted
2015-04-22
Last updated
2026-02-18

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02424123. Inclusion in this directory is not an endorsement.