Multiple Sclerosis Clinical Trial
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.
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
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