Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
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
Marburg's Variant of Multiple Sclerosis
Balo's Concentric Sclerosis
Acute Transverse Myelitis
Procedure: Plasma exchange
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
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|