Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT03744351
Eligibility Criteria:
Inclusion Criteria:
Regarding MS patients (remitting or progressive untreated):
* Adult (age greater than or equal to 18 years) of both sexes;
* MS fulfilling the criteria of McDonald 2017;
* Remittent or progressive form;
* No immunomodulatory or immunosuppressive therapy for at least 3 months;
* Free, informed and written consent signed by the patient.
Regarding Clinically Isolated Syndrome:
* Adult (age greater than or equal to 18 years) of both sexes;
* Clinically isolated syndrome suggestive of MS (at least two typical lesions in two different locations);
* Patient receiving a Lumbar Puncture (PL) for diagnostic purposes;
* No immunomodulatory or immunosuppressive therapy for at least 3 months;
* Free, informed and written consent signed by the patient.
Regarding non-MS patients with neurological inflammatory disease:
* Adult (age greater than or equal to 18 years) of both sexes;
* Patient with non-MS neurological inflammatory disease (examples: meningitis, neurolupus, neurosarcoidosis...);
* Patients with PL for diagnostic or surveillance purposes;
* No immunomodulatory or immunosuppressive therapy for at least 3 months;
* Free, informed and written consent signed by the patient.
Regarding healthy volunteers:
* Adult (age greater than or equal to 18 years) of both sexes;
* Free, informed and written consent signed by the volunteer.
Exclusion Criteria:
Regarding all patients:
* Pregnancy;
* Breastfeeding;
* Treatment with corticotherapy in the last month;
* Patient not affiliated to social security;
* Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
Regarding healthy volunteers:
* Pregnancy;
* Breastfeeding;
* Not affiliated to social security;
* Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03744351
Study Brief:
Protocol Section:
NCT03744351