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EpilepsySeizS100BNCT02424123

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

An observational study of Epilepsy and Seizures, Epileptic, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Epilepsy, Seizures, Epileptic
How many people
37 participants
Where
2 sitesFrance
Study dates
11 Oct 2016to 30 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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 in an exclusion period determined by a previous study.
  • The patient is under judicial protection.
  • The patient refuses to sign the consent.
  • It is impossible to correctly inform the patient.
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  • 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).

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • APHM - Hôpital Nord

    Marseille, 13915

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

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

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.

Read the detailed description

The secondary objectives of this study are to investigate the:

  1. 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.
  2. Correlation of S100B with IL-1b, IL-6, NSE serum levels at the same time points.
  3. Association of serology data with: a) EEG profile (normal/abnormal); b) recurrence of seizures (Y/N).
  4. Comparison of S100B serum levels in lesional vs non-lesional patients. F) Establishment of a bio-bank (serum and cells).
Medical subject headings
Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02424123
Study groupRoleWhat they receive
The study populationThe 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum S100B level

    ng/ml

    Measured: Day 0 (T0+6 hours)

  2. Serum S100B level

    ng/ml

    Measured: Day 0 (T0+12 hours)

  3. Seizure recurrence within 1 year

    yes/no

    Measured: 12 months

Secondary outcomes (15)

  1. Serum S100B level

    ng/ml

    Measured: Between days 14 and 28

  2. Serum S100B level

    ng/ml

    Measured: 6 months

  3. Serum S100B level

    ng/ml

    Measured: 12 months

  4. Serum S100B level

    ng/ml

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

  5. Serum IL-1b level

    pg/mL

    Measured: Day 0 (T0+6 hours)

  6. Serum IL-1b level

    pg/mL

    Measured: Day 0 (T0+12 hours)

  7. Serum IL-1b level

    pg/mL

    Measured: Between days 14 and 28

  8. Serum IL-6 level

    pg/mL

    Measured: Day 0 (T0+6 hours)

  9. Serum IL-6 level

    pg/mL

    Measured: Day 0 (T0+12 hours)

  10. Serum IL-6 level

    pg/mL

    Measured: Between days 14 and 28

  11. Serum NSE level

    µg/dL

    Measured: Day 0 (T0+6 hours)

  12. Serum NSE level

    µg/dL

    Measured: Day 0 (T0+12 hours)

  13. Serum NSE level

    µg/dL

    Measured: Between days 14 and 28

  14. Electro encephalogram profile

    Measured: Day 0

  15. Electro encephalogram profile

    Measured: Between days 14 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2015 (estimated)
  2. Study start11 Oct 2016
  3. Primary completion30 Jul 2020
  4. Study completion30 Jul 2020

Why it stopped: recruitment shortage

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424123
Sponsor's protocol ID
LOCAL/2014/ET-02
Other IDs
2015-A00157-42
Acronym
SeizS100B
Status last verified
Feb 2026
First submitted
20 Apr 2015
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Seizures, Epileptic, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: recruitment shortage). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum S100B level (time frame: Day 0 (T0+6 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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