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Plasma Exchanges in Multiple Sclerosis (MS) Relapses (PLASMASEP)

Primary Purpose

Multiple Sclerosis, Multiple Sclerosis, Acute Relapsing

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
plasma exchange
sham exchanges procedure
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, plasma exchange

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux
  • Service de neurologie - CHU de Clermont-Ferrand
  • Service de Neurologie - CHRU de Lille
  • Service de Neurologie - CHU de nancy
  • Service de neurologie - CHU de Nantes
  • Service de Neurologie - CHU de Starsbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

plasma exchange

sham exchange

Arm Description

6 plasma exchanges during 2 weeks after randomization

6 sham plasma exchanges during 2 weeks after randomization

Outcomes

Primary Outcome Measures

4 graded-scale of improvement based on objective scales and functional assessment after 1 month

Secondary Outcome Measures

4 graded-scale of improvement based on objective scales and functional assessment
change in functional evaluation by visual analogic scales (VAS)
change in functional scores (kurtzke FS)
change of EDSS scores

Full Information

First Posted
August 9, 2011
Last Updated
January 12, 2018
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01442233
Brief Title
Plasma Exchanges in Multiple Sclerosis (MS) Relapses
Acronym
PLASMASEP
Official Title
Randomized Clinical Trial of Plasma Exchanges Versus Sham Plasma Exchanges in Disabling Multiple Sclerosis Acute Relapses Refractory to Steroid Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 8, 2012 (Actual)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 established evidence of their efficacy.
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 accumulates in spite of steroid treatment and did not recover. Plasma exchanges (PE) are frequently used to treat the severe attacks of inflammatory demyelination in the central nervous system resistant to steroids (Tumani, 2008). This strategy has been evaluated so far only in few studies. Only one randomized controlled study has been performed (Weinshenker et al, 1999) including patients with very severe attacks of inflammatory demyelinating diseases of various origin (MS, acute transverse myelitis, acute disseminated encephalomyelitis, neuromyelitis optica), not improved after a treatment by steroids. A moderate or important improvement of incapacity was observed in 8 cases out of 19 (42.1%) after treatment by PE against 1 out of 17 (5.9%) after sham treatment. This study concerned only 12 patients having a relapse of MS. Based on this first controlled study and the experience of treatment of 42 MS patients in the department of Neurology of the University Hospital Pellegrin (CHU de Bordeaux) we designed a randomized controlled study of PE against sham PE in moderate to severe acute exacerbations of MS not responding to steroid treatment. The purpose is to compare plasma exchanges versus sham exchanges on residual disability in MS patients with a demyelinating inflammatory episode (MS or syndrome with high risk of MS) experiencing a disabling relapse not improved after steroid treatment. The primary end-point will be evaluated one month after start of therapy. Secondary endpoints include safety and evaluation of improvement at 3 and 6 months and evaluation of safety

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Multiple Sclerosis, Acute Relapsing
Keywords
multiple sclerosis, plasma exchange

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plasma exchange
Arm Type
Experimental
Arm Description
6 plasma exchanges during 2 weeks after randomization
Arm Title
sham exchange
Arm Type
Sham Comparator
Arm Description
6 sham plasma exchanges during 2 weeks after randomization
Intervention Type
Procedure
Intervention Name(s)
plasma exchange
Intervention Description
6 plasma exchange each 48 hours during 2 weeks after randomization
Intervention Type
Procedure
Intervention Name(s)
sham exchanges procedure
Intervention Description
6 sham exchanges each 48 hours during 2 weeks after randomization
Primary Outcome Measure Information:
Title
4 graded-scale of improvement based on objective scales and functional assessment after 1 month
Time Frame
after 1 month
Secondary Outcome Measure Information:
Title
4 graded-scale of improvement based on objective scales and functional assessment
Time Frame
after 3 months and 6 months
Title
change in functional evaluation by visual analogic scales (VAS)
Time Frame
after 1 month, 3 and 6 months
Title
change in functional scores (kurtzke FS)
Time Frame
after 1 month, 3 and 6 months
Title
change of EDSS scores
Time Frame
after 1 month, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda WITTKOP, MD PhD
Organizational Affiliation
university bordeaux hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruno BROCHET, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruno BROCHET, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service de neurologie - CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Service de Neurologie - CHRU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Service de Neurologie - CHU de nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Service de neurologie - CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Service de Neurologie - CHU de Starsbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

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