Status:
COMPLETED
Plasma Exchanges in Multiple Sclerosis (MS) Relapses
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Multiple Sclerosis
Multiple Sclerosis, Acute Relapsing
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 establis...
Detailed Description
Multiple sclerosis (MS) relapses are usually treated by steroids but some patients did not respond well to this treatment. In more than 40 % of MS patients experiencing relapses, residual disability a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2017
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01442233
Start Date
March 8 2012
End Date
September 21 2017
Last Update
January 16 2018
Active Locations (6)
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1
Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, France, 33000
2
Service de neurologie - CHU de Clermont-Ferrand
Clermont-Ferrand, France
3
Service de Neurologie - CHRU de Lille
Lille, France, 59000
4
Service de Neurologie - CHU de nancy
Nancy, France, 54000