HeadacheS100B-CéphNCT02683304
S100B in the Care of Non-traumatic Headaches in the Emergency Department
A study testing Plasma S100B levels at inclusion and Magnetic resonance imaging in people with Headache, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Headache
- What is being tested?
- Plasma S100B levels at inclusion and Magnetic resonance imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2017to 20 Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient has nontraumatic headache pain with a visual analog scale > 3
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- The patient has a contraindication for magnetic resonance imaging
- Patients suffering from the following diseases: Alzheimer's disease, multiple sclerosis, Creutzfeldt-Jakob disease, melanoma, trisomy 21.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department
The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches.
For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.
Read more
If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.
The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.
Read the detailed description
The secondary objectives of this study are:
- To seek an association between S100B protein levels and the onset of pain depending on whether it is more or less than 3 hours.
- To assess the association between S100B protein levels and mortality at day 28.
- To evaluate the association between S100B protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay.
- To evaluate the prognostic value of determination of S100B protein on the occurrence of a secondary headache at 1 month.
- Conditions
- Headache
- Being tested
- Plasma S100B levels at inclusion, Magnetic resonance imaging
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma S100B levels at inclusionBiological
Patients will have blood drawn to measure plasma S100B levels at inclusion.
Magnetic resonance imagingDevice
If not performed under emergency conditions, patients will have an MRI on days 2-4.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Experimental | The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital Receives: Biological: Plasma S100B levels at inclusion; Device: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
S100B protein level (ng/ml)
Measured: Day 0
The presence/absence of a clinically significant anomaly on the MRI scan
Measured: Days 2-4
Final diagnostic as established by an expert committee
The diagnostic posed is either "primary headache" or "secondary headache"
Measured: Month 1
Secondary outcomes (12)
Mortality (yes/no)
"Mortality" refers to whether or not the subject is still alive.
Measured: Month 1
Length of stay in the emergency department (days)
Measured: Month 1
Length of stay in the hospital (days)
Measured: Month 1
White blood cell count in cerebral spinal fluid
Measured: Month 1
Red blood cell count in cerebral spinal fluid
Measured: Month 1
Cerebral spinal fluid glucose level
Measured: Month 1
Cerebral spinal fluid protein level
Measured: Month 1
Cerebral spinal fluid chloride level
Measured: Month 1
Presence/absence of enterovirus in cerebral spinal fluid
Based on qualitative result from ELISA laboratory exam.
Measured: Month 1
Presence/absence of herpes virus in cerebral spinal fluid
Based on qualitative result from ELISA laboratory exam.
Measured: Month 1
Presence/absence of cerebral imaging indicating an ischemic or hemorrhagic stroke, subarachnoid hemorrhage, an expansive process, cerebral trombophlebitis cerebral or other abnormalities suggestive of a secondary cause of headache.
Measured: Month 1
Secondary headache onset: yes/no
Was there secondary headache onset by month 1?
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start10 Mar 2017
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Genre Grandpierre, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683304
- Sponsor's protocol ID
- LOCAL/2015/RGG-01
- Other IDs
- 2016-A00013-48
- Acronym
- S100B-Céph
- Status last verified
- Jul 2020
- First submitted
- 19 Jan 2016
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grau-Mercier L, Grandpierre RG, Alonso S, Savey A, Le Floch A, de Oliveira F, Masia T, Jory N, Coisy F, Claret PG. S100B serum level: A relevant biomarker for the management of non-traumatic headaches in emergency care? Am J Emerg Med. 2023 Jun;68:132-137. doi: 10.1016/j.ajem.2023.03.036. Epub 2023 Mar 25.
PubMed 37001377
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department
- ClinicalTrials.gov ID
- NCT02683304
- Acronym / sponsor ID
- S100B-Céph / LOCAL/2015/RGG-01
- Conditions
- Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches.
For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.
If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.
The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.
Detailed description
The secondary objectives of this study are:
- To seek an association between S100B protein levels and the onset of pain depending on whether it is more or less than 3 hours.
- To assess the association between S100B protein levels and mortality at day 28.
- To evaluate the association between S100B protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay.
- To evaluate the prognostic value of determination of S100B protein on the occurrence of a secondary headache at 1 month.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | Biological: Plasma S100B levels at inclusion, Device: Magnetic resonance imagingThe study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient has nontraumatic headache pain with a visual analog scale > 3
Key exclusion criteria (8 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma S100B levels at inclusionPatients will have blood drawn to measure plasma S100B levels at inclusion. | Biological | The study population |
| Magnetic resonance imagingIf not performed under emergency conditions, patients will have an MRI on days 2-4. | Device | The study population |
Primary outcome
S100B protein level (ng/ml)
Time frame: Day 0
The presence/absence of a clinically significant anomaly on the MRI scan
Time frame: Days 2-4
Final diagnostic as established by an expert committee
Time frame: Month 1
The diagnostic posed is either "primary headache" or "secondary headache"
12 secondary outcomes
Mortality (yes/no)
Time frame: Month 1
Length of stay in the emergency department (days)
Time frame: Month 1
Length of stay in the hospital (days)
Time frame: Month 1
White blood cell count in cerebral spinal fluid
Time frame: Month 1
Red blood cell count in cerebral spinal fluid
Time frame: Month 1
Cerebral spinal fluid glucose level
Time frame: Month 1
Cerebral spinal fluid protein level
Time frame: Month 1
Cerebral spinal fluid chloride level
Time frame: Month 1
Presence/absence of enterovirus in cerebral spinal fluid
Time frame: Month 1
Presence/absence of herpes virus in cerebral spinal fluid
Time frame: Month 1
Presence/absence of cerebral imaging indicating an ischemic or hemorrhagic stroke, subarachnoid hemorrhage, an expansive process, cerebral trombophlebitis cerebral or other abnormalities suggestive of a secondary cause of headache.
Time frame: Month 1
Secondary headache onset: yes/no
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 37001377Grau-Mercier L, Grandpierre RG, Alonso S, Savey A, Le Floch A, de Oliveira F, Masia T, Jory N, Coisy F, Claret PG. S100B serum level: A relevant biomarker for the management of non-traumatic headaches in emergency care? Am J Emerg Med. 2023 Jun;68:132-137. doi: 10.1016/j.ajem.2023.03.036. Epub 2023 Mar 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Genre Grandpierre, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma S100B levels at inclusion and Magnetic resonance imaging in people with Headache, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
S100B protein level (ng/ml) (time frame: Day 0). 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 NCT02683304, which also lists 1 linked publication.
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 1 Dec 2025.