Plasma swap shows promise for tough MS attacks
NCT ID NCT01442233
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether plasma exchange (a blood-filtering treatment) helps people with multiple sclerosis who have severe flare-ups that don't get better with steroids. Thirty-eight adults took part, and researchers compared real plasma exchange to a sham procedure. The main goal was to see if patients improved after one month using standard disability scales.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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38 people
The number who actually took part.
- Started
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Mar 2012
- Finished
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Sep 2017
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service de Neurologie - CHRU de Lille
Lille, 59000, France
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Service de Neurologie - CHU de Starsbourg
Strasbourg, 67000, France
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Service de Neurologie - CHU de nancy
Nancy, 54000, France
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Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, 33000, France
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Service de neurologie - CHU de Clermont-Ferrand
Clermont-Ferrand, France
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Service de neurologie - CHU de Nantes
Nantes, 44000, France
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Other studies related to the condition(s) this trial covers.
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