Plasma Exchanges in Multiple Sclerosis (MS) Relapses (PLASMASEP)
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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 |
- 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 ]
- 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 |
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| 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 |
| 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 | |
| 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: | April 18, 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 May 22, 2013