Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
Recruitment status was: Active, not recruiting
I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.
|Acute Disseminated Encephalomyelitis Devic's Syndrome Marburg's Variant of Multiple Sclerosis Balo's Concentric Sclerosis Acute Transverse Myelitis||Procedure: Plasma exchange||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||January 1995|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by disease type; each stratum is randomized separately.
The first group of patients receives a true plasma exchange using continuous-flow centrifugation with serum albumin and crystalloid replacement every 2 days for a total of 7 exchanges.
The second group receives a sham plasma exchange with no centrifugation every 2 days for a total of 7 exchanges.
Patients cross to the alternate therapy if there is less than a moderate improvement by day 14. The treatment decision is based on a blinded neurologic assessment.
Concurrent corticosteroids and other immunosuppressants, and high-dose barbiturates are not allowed.
Patients are followed at 1 and 6 months after the last exchange.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004645
|Study Chair:||Brian G. Weinshenker||Mayo Clinic|