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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01442233
Eligibility Criteria:
Inclusion Criteria:
* Probable relapsing-remitting MS (RRMS) according to Polman et al criteria 2010. or clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS).
* Age 18-65
* EDSS before the current relapse \<6.5
* Acute relapse (optic neuritis, motor pyramidal relapse, cerebellar relapse, oculomotor relapse) since less than 2 months
* Having been treated by IV or orally steroid (Methylprednisolone, 1g/d for at least 3 days), followed or not by oral tapering.
* The current relapse inducing a significant clinical deterioration as compared to pre-relapse status and persisting 30 days after starting steroids.
* Loss of visual acuity more than 30% on one ot both eyes;
* Or: increase of 1 point pyramidal or brainstem functional system score (FSS) (if score ≥ 3) or cerebellar FSS (if score ≥ 2).
* Or: reduced walking distance associated with an increase ≥ 0.5 point EDSS if EDSS ≥4.0;
* Having signed informed consent.
* affiliated to the French Social Security
Exclusion Criteria:
* Infection
* Improving relapse.
* Other disease interfering with evaluation.
* Current treatment by immunosuppressive drug (as cyclophosphamide and mitoxantrone) or interrupted for less than 3 months.
* Modification of DMT since less than 1 month.
* Physical or psychic disease interfering with evaluation or consent.
* Participation to another trial in the last 3 months.
* Inability to establish peripheral central intravenous access;
* Cerebral, autonomic, cardiac or other conditions with increased risk from hypovolemia
* Pregnancy or breast-feeding.
* Woman in age to procreate without effective contraception
* Treatment by monoclonal antibody.
* Progressive course of MS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01442233
Study Brief:
Protocol Section:
NCT01442233