Plasma Exchanges in Multiple Sclerosis (MS) Relapses

NCT01442233 | Completed Phase 3 DMC

• 2 other identifiers: CHUBX 2010/462010-024159-95
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 6

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.

Conditions

Multiple Sclerosis; Multiple Sclerosis, Acute Relapsing

Keywords

multiple sclerosis; plasma exchange

Outcome Measures

Primary Outcomes (1)

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

  after 1 month

Secondary Outcomes (4)

• 4 graded-scale of improvement based on objective scales and functional assessment

  after 3 months and 6 months

• change in functional evaluation by visual analogic scales (VAS)

  after 1 month, 3 and 6 months

• change in functional scores (kurtzke FS)

  after 1 month, 3 and 6 months

• change of EDSS scores

  after 1 month, 3 and 6 months

Study Arms (2)

plasma exchange

EXPERIMENTAL

6 plasma exchanges during 2 weeks after randomization

Procedure: plasma exchange

sham exchange

SHAM COMPARATOR

6 sham plasma exchanges during 2 weeks after randomization

Procedure: sham exchanges procedure

Interventions

plasma exchange PROCEDURE

6 plasma exchange each 48 hours during 2 weeks after randomization

plasma exchange

sham exchanges procedure PROCEDURE

6 sham exchanges each 48 hours during 2 weeks after randomization

sham exchange

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (6)

Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux

Bordeaux, 33000, France

Location

Service de neurologie - CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

Service de Neurologie - CHRU de Lille

Lille, 59000, France

Location

Service de Neurologie - CHU de nancy

Nancy, 54000, France

Location

Service de neurologie - CHU de Nantes

Nantes, 44000, France

Location

Service de Neurologie - CHU de Starsbourg

Strasbourg, 67000, France

Location

Related Publications (1)

• Brochet B, Deloire M, Germain C, Ouallet JC, Wittkop L, Dulau C, Perez P, Thevenot F, De Seze J, Zephir H, Vermersch P, Pittion S, Debouverie M, Laplaud DA, Clavelou P, Ruet A. Double-blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate-to-severe relapses of multiple sclerosis. J Clin Apher. 2020 Aug;35(4):281-289. doi: 10.1002/jca.21788. Epub 2020 May 5.

  PMID: 32369661 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Linda WITTKOP, MD PhD

  university bordeaux hospital

  STUDY CHAIR

• Bruno BROCHET, MD

  University Hospital Bordeaux, France

  STUDY DIRECTOR

• Bruno BROCHET, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: September 28, 2011
• Study Start: March 8, 2012
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: May 14, 2026

Record last verified: 2018-01

Locations

FR (6)