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

This study is currently recruiting participants.
Verified October 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01442233
First received: August 9, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Multiple Sclerosis, Acute Relapsing
Procedure: plasma exchange
Procedure: sham exchanges procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Plasma Exchanges Versus Sham Plasma Exchanges in Disabling Multiple Sclerosis Acute Relapses Refractory to Steroid Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 4 graded-scale of improvement based on objective scales and functional assessment after 1 month [ Time Frame: after 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 4 graded-scale of improvement based on objective scales and functional assessment [ Time Frame: after 3 months and 6 months ] [ Designated as safety issue: No ]
  • change in functional evaluation by visual analogic scales (VAS) [ Time Frame: after 1 month, 3 and 6 months ] [ Designated as safety issue: No ]
  • change in functional scores (kurtzke FS) [ Time Frame: after 1 month, 3 and 6 months ] [ Designated as safety issue: No ]
  • change of EDSS scores [ Time Frame: after 1 month, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: plasma exchange
6 plasma exchanges during 2 weeks after randomization
Procedure: plasma exchange
6 plasma exchange each 48 hours during 2 weeks after randomization
Sham Comparator: sham exchange
6 sham plasma exchanges during 2 weeks after randomization
Procedure: sham exchanges procedure
6 sham exchanges each 48 hours during 2 weeks after randomization

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 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Probable relapsing-remitting MS (RRMS) according to Polman et al criteria 2010.
  • 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 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 15 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442233

Contacts
Contact: Bruno BROCHET, MD (0)5 56 79 55 21 bruno.brochet@chu-bordeaux.fr
Contact: Mathilde DELOIRE, PhD (0)5 57 57 48 17 mathilde.grassin@bb-luni.u-bordeaux2.fr

Locations
France
Féderation Des Neusciences Cliniques Recruiting
Bordeaux, France, 33000
Contact: Bruno BROCHET, MD         
Contact: Mathilde DELOIRE, PhD         
Principal Investigator: Bruno BROCHET, MD         
Service de Neurologie - CHRU de Lille Recruiting
Lille, France, 59000
Principal Investigator: Patrick VERMERSCH, MD         
Service de Neurologie - CHU de nancy Recruiting
Nancy, France, 54000
Principal Investigator: Marc DEBOUVERIE, MD         
CHU de Nantes Not yet recruiting
Nantes, France, 44000
Contact: David LAPLAUD, MD         
Principal Investigator: David LAPLAUD, MD         
Service de Neurologie - CHU de Starsbourg Recruiting
Strasbourg, France, 67000
Principal Investigator: Jerome DESEZE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Geneviève CHENE, MD PhD university bordeaux hospital
Study Director: Bruno BROCHET, MD University Hospital Bordeaux, France
Principal Investigator: Bruno BROCHET, MD University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01442233     History of Changes
Other Study ID Numbers: CHUBX 2010/46
Study First Received: August 9, 2011
Last Updated: October 21, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
multiple sclerosis
plasma exchange

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014