Spots Global Cancer Trial Database for Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone

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Trial Identification

Brief Title: Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone

Official Title:

Study ID: NCT00004645

Conditions

Acute Disseminated Encephalomyelitis

Devic's Syndrome

Marburg's Variant of Multiple Sclerosis

Balo's Concentric Sclerosis

Acute Transverse Myelitis

Interventions

Plasma exchange

Study Description

Brief Summary: OBJECTIVES: 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.

Detailed Description: 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.