An observational study in Headache, Migraine and Hemorrhage, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 71 studies in Migraine Disorders with a site in France — 14 open to participants now, 20 under way, 6 of them phase 3. Migraine Disorders · France.
Among the 71 studies in Migraine Disorders with a site in France, this one is the 16th largest by enrollment of the 20 observational ones that give a count, is one of 3 that started in 2018, is one of 20 observational ones, and was the 26th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →14 of the 71 studies in Migraine Disorders with a site in France are open now. Recruiting first, the newest first:
University Hospital, Clermont-Ferrand · Sites in France
Ages 18–50 · Women only · Healthy volunteers
University Hospital, Clermont-Ferrand · Sites in France
Ages 18–50
University Hospital, Clermont-Ferrand · Sites in France
Ages 18–50 · Women only · Healthy volunteers
Hôpital Européen Marseille · Sites in France
Ages 18–60
University Hospital, Clermont-Ferrand · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
71 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 63 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.
Median enrollment 450 across the 51 interventional studies, 155 across the 20 observational. Of the 44 that completed or were terminated, 19 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 71 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer has 1 study filed under Migraine Disorders — fewer than ten, so there is no comparison to draw.
7 of the studies in Migraine Disorders with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07018700Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine | 2027-03 |
| NCT07018713Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine | 2027-03 |
| NCT06426316University Hospital, Clermont-FerrandThe Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology. | 2027-04-30 |
| NCT07598045University Hospital, Clermont-FerrandEfficacy of Anti-IL-6 Treatments on Migraine in Patients Treated With Anti-IL-6 for a Rheumatological Condition | 2027-05-26 |
| NCT06625060IpsenA Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults | 2027-10-31 |
Add all 7 to your calendar (.ics) → With an account.
Among the 71 studies in Migraine Disorders with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine the negative predictive value of protein S100B that could exclude subarachnoid and intracranial haemorrhage for patient that present severe headache within the last 3 hours.
This study will be proposed to every patient that correspond to eligibility criteria, such as presenting a severe headache (Visual Analog Scale ≥ 6/10) within 3 hours before arriving to the emergency.
After signing the informed consent, a blood sample will be taken in order to dosage S100B protein of each patient, and then they will have a brain scan.
The trial ends after the brain scan for each patient. Results of brain scans will be compared with results of S100B dosage.
The population will be recruited in the emergency unit
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological
Evaluate the interest of PS100B dosage in the severe headache therapeutic management
Negative predictive value of PS100B dosage below the reference value of 0.10 µG/L for intracerebral haemorrhage lesion
Time frame: 15 months
Frequency of Intracranial Bleeding in patient with severe headache
Incidence of intracranial bleeding in patient with severe headache
Time frame: 15 months
Frequency of subarachnoid hemorrhage in patient with severe headache
Incidence of subarachnoid haemorrhage in patient with severe headache
Time frame: 15 months
Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion
Incidence of intracranial haemorrhage in migraine patient with severe headache at inclusion
Time frame: 15 months
Evaluate the number of lumbar puncture that could have been avoided
The ratio of patient with a normal scan and a PS100 dosage \< 0.10µg/L, on patient eligible for lumbar puncture according to the usual practice
Time frame: 15 months
Evaluate the number of cerebral scan that could have been avoided
The ratio of patient with a normal scan and a PS100 dosage \< 0.10 µg/L, on patient eligible for cerebral scan according to the usual practice
Time frame: 15 months
Evaluate the number of lumbar puncture's complications that could have been avoided.
The ratio of patients with PS100 \< 0.10µg/L and normal cerebral scan on the total number of patients included
Time frame: 15 months
Plan to share: No — There is no IPD sharing plan
Ran from Oct 2018 to primary completion in Jan 2020, 15 months.
Of 132 non-industry observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 72. This study's 15 months is below that.
Counting every sponsor, half of 160 studies reached it within 27 months; a quarter within 13 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer