Overview

This trial is active, not recruiting.

Conditions acute disseminated encephalomyelitis, devic's syndrome, marburg's variant of multiple sclerosis, balo's concentric sclerosis, acute transverse myelitis
Treatment plasma exchange
Phase phase 3
Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator Mayo Clinic
Start date January 1995
Trial size 22 participants
Trial identifier NCT00004645, 199/11693, MAYOC-29493

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Idiopathic inflammatory demyelinating syndrome, as follows: biopsy-proven if necessary - established diagnosis of multiple sclerosis (MS) using Poser criteria; acute disseminated encephalomyelitis; Marburg's variant of MS Balo's concentric sclerosis - Eligible without biopsy: acute transverse myelitis; Devic's syndrome - Acute neurologic deficit markedly affecting consciousness, language, or brainstem/spinal cord function, i.e., aphasia, paraplegia, coma, quadriplegia, hemiplegia, severe organic brain syndrome - Deficit unresponsive to 5 days of high-dose intravenous methylprednisolone (MePRDL), as follows: deficit duration of 21 days to 3 months AND no improvement 14 days after beginning MePRDL OR deficit duration of 12 to 20 days AND continued deterioration after completion of MePRDL - No chronically progressive demyelinating disease - No HIV-associated demyelinating syndrome - No progressive multifocal leukoencephalopathy - No optic neuritis --Prior/Concurrent Therapy-- - No more than 3 months of prior steroid therapy Failure on prior MePRDL required Minimum dose 7 mg/kg per day for 5 days - At least 6 weeks since other immunosuppressives, e.g., cyclophosphamide, azathioprine, cyclosporine --Patient Characteristics-- - Renal: Creatinine less than 1.5 mg/dL - Cardiovascular: No hypovolemia; no infarction; no vasculitis; no other major systemic cardiovascular illness - Pulmonary: No major respiratory illness - Other: No infection, including hepatitis or human immunodeficiency virus; no recent intravenous drug abuse; no high-risk sexual behavior; no cardiac, cerebrovascular, or autonomic dysfunction that would increase risk of hypotension; no other major systemic illness that would preclude protocol therapy; no pregnant or nursing women; negative serum pregnancy test required of fertile women; effective contraception required

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Office of Rare Diseases (ORD).