A Phase 3 interventional study of plasma exchange and sham exchanges procedure in Multiple Sclerosis and Multiple Sclerosis, Acute Relapsing, sponsored by University Hospital, Bordeaux. Completed at 6 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and 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.
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
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 38 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The current relapse inducing a significant clinical deterioration as compared to pre-relapse status and persisting 30 days after starting steroids.
Exclusion Criteria:
6 plasma exchanges during 2 weeks after randomization
Procedure: plasma exchange
6 sham plasma exchanges during 2 weeks after randomization
Procedure: sham exchanges procedure
6 plasma exchange each 48 hours during 2 weeks after randomization
6 sham exchanges each 48 hours during 2 weeks after randomization
4 graded-scale of improvement based on objective scales and functional assessment after 1 month
Time frame: after 1 month
4 graded-scale of improvement based on objective scales and functional assessment
Time frame: after 3 months and 6 months
change in functional evaluation by visual analogic scales (VAS)
Time frame: after 1 month, 3 and 6 months
change in functional scores (kurtzke FS)
Time frame: after 1 month, 3 and 6 months
change of EDSS scores
Time frame: after 1 month, 3 and 6 months
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux