Multiple Sclerosis Clinical Trial
— PLASMASEPOfficial title:
Randomized Clinical Trial of Plasma Exchanges Versus Sham Plasma Exchanges in Disabling Multiple Sclerosis Acute Relapses Refractory to Steroid Treatment
Verified date | January 2018 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | September 21, 2017 |
Est. primary completion date | September 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux | Bordeaux | |
France | Service de neurologie - CHU de Clermont-Ferrand | Clermont-Ferrand | |
France | Service de Neurologie - CHRU de Lille | Lille | |
France | Service de Neurologie - CHU de nancy | Nancy | |
France | Service de neurologie - CHU de Nantes | Nantes | |
France | Service de Neurologie - CHU de Starsbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 4 graded-scale of improvement based on objective scales and functional assessment after 1 month | after 1 month | ||
Secondary | 4 graded-scale of improvement based on objective scales and functional assessment | after 3 months and 6 months | ||
Secondary | change in functional evaluation by visual analogic scales (VAS) | after 1 month, 3 and 6 months | ||
Secondary | change in functional scores (kurtzke FS) | after 1 month, 3 and 6 months | ||
Secondary | change of EDSS scores | after 1 month, 3 and 6 months |
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