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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|ClinicalTrials.gov Identifier: NCT00004645|
Recruitment Status : Unknown
Verified March 1999 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Disseminated Encephalomyelitis Devic's Syndrome Marburg's Variant of Multiple Sclerosis Balo's Concentric Sclerosis Acute Transverse Myelitis||Procedure: Plasma exchange||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Study Start Date :||January 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004645
|Study Chair:||Brian G. Weinshenker||Mayo Clinic|