NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Plasma Exchanges in Multiple Sclerosis (MS) Relapses
Plasma Exchanges in Multiple Sclerosis (MS) Relapses
CompletedPhase 3
Sponsor: University Hospital, Bordeaux
Conditions: Multiple Sclerosis, Multiple Sclerosis, Acute Relapsing
Interventions: plasma exchange, sham exchanges procedure
Countries: France
In more than 40 % of multiple sclerosis (MS) patients experiencing relapse, residual disability accumulates in spite of steroid treatment. Plasma exchanges are frequently used but there is no established evidence of their efficacy.
Eligibility overview
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
Locations (6)
- Bordeaux, France
- Clermont-Ferrand, France
- Lille, France
- Nancy, France
- Nantes, France
- Strasbourg, France