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Multiple SclerosisPhase 3PLASMASEPNCT01442233

Plasma Exchanges in Multiple Sclerosis (MS) Relapses

A Phase 3 study testing plasma exchange in people with Multiple Sclerosis and Multiple Sclerosis, Acute Relapsing, run by University Hospital, Bordeaux at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
plasma exchange
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
6 sitesFrance
Study dates
8 Mar 2012to 21 Sep 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux

    Bordeaux, 33000

  • Service de neurologie - CHU de Clermont-Ferrand

    Clermont-Ferrand

  • Service de Neurologie - CHRU de Lille

    Lille, 59000

  • Service de Neurologie - CHU de nancy

    Nancy, 54000

  • Service de neurologie - CHU de Nantes

    Nantes, 44000

  • Service de Neurologie - CHU de Starsbourg

    Strasbourg, 67000

Other trials in France

About this study

Official title: Randomized Clinical Trial of Plasma Exchanges Versus Sham Plasma Exchanges in Disabling Multiple Sclerosis Acute Relapses Refractory to Steroid Treatment

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.

Read the 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

Being tested
plasma exchange, sham exchanges procedure
Keywords
multiple sclerosis, plasma exchange
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • plasma exchangeProcedure or surgery

    6 plasma exchange each 48 hours during 2 weeks after randomization

  • sham exchanges procedureProcedure or surgery

    6 sham exchanges each 48 hours during 2 weeks after randomization

Study groups in NCT01442233
Study groupRoleWhat they receive
plasma exchangeExperimental6 plasma exchanges during 2 weeks after randomization
Receives: Procedure: plasma exchange
sham exchangeSham comparator6 sham plasma exchanges during 2 weeks after randomization
Receives: Procedure: sham exchanges procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: after 1 month

Secondary outcomes (4)

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

    Measured: after 3 months and 6 months

  2. change in functional evaluation by visual analogic scales (VAS)

    Measured: after 1 month, 3 and 6 months

  3. change in functional scores (kurtzke FS)

    Measured: after 1 month, 3 and 6 months

  4. change of EDSS scores

    Measured: after 1 month, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study start8 Mar 2012
  3. Primary completion21 Sep 2017
  4. Study completion21 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442233
Sponsor's protocol ID
CHUBX 2010/46
Other IDs
2010-024159-95
Acronym
PLASMASEP
Status last verified
Jan 2018
First submitted
9 Aug 2011
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32369661

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing plasma exchange in people with Multiple Sclerosis and Multiple Sclerosis, Acute Relapsing, run by University Hospital, Bordeaux at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

4 graded-scale of improvement based on objective scales and functional assessment after 1 month (time frame: after 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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